Clinical Research Directory

Lemborexant on Perioperative Sleep Quality in Patients With Brain Tumor Undergoing Surgery

This study tests whether lemborexant can improve perioperative sleep quality in people with brain tumor undergoing surgery. Adults with brain tumor scheduled for surgery may join. Participants will be randomly assigned to take lemborexant or a placebo the night before surgery. Researchers will measure sleep quality, anesthesia recovery, pain, postoperative recovery, and other outcomes.

Impact of a Radiologic and Immunologic Signature on Cerebral Efficacy of Treatments in Lung Cancers With Brain Metastasis

Non-small cell lung cancer frequently spreads to the brain, and brain metastases are associated with poor prognosis and limited treatment response. This retrospective study will investigate whether quantitative features extracted from brain magnetic resonance imaging (MRI), known as radiomic features, are associated with the immune characteristics of brain metastases assessed by bulk RNA sequencing. The main objective is to identify relationships between MRI-based radiomic signatures and tumor immune profiles. A secondary objective is to determine whether radiomic, transcriptomic, or combined radio-transcriptomic signatures can help predict cerebral progression during immunotherapy. The study hypothesis is that MRI-based radiomic signatures may reflect the immune environment of brain metastases and could provide a non-invasive approach for predicting treatment response.

Adverse Events During Physical Therapy in Neurocritical ICU Patients

The goal of this observational study is to identify the clinical, neurological, hemodynamic, and respiratory variables associated with the occurrence of adverse events during physical therapy interventions in adult neurocritical patients admitted to the Intensive Care Unit (ICU). The main questions it aims to answer are: What clinical, neurological, hemodynamic, and respiratory factors are associated with adverse events during physical therapy in neurocritical patients? What is the incidence and type of adverse events that occur most frequently during physical therapy in this patient population? Researchers will compare clinical and physiological data between patients who experienced adverse events during physical therapy and those who did not, to determine risk factors associated with these complications. Participants' data will be retrospectively collected from medical records without performing new clinical interventions.

Study of Abemaciclib and Elacestrant in Participants With Brain Metastasis Due to ER+/HER-2- Breast Cancer

This is a multi-site, global, open-label study that includes a phase 1b evaluation of elacestrant in combination with abemaciclib in women and men with brain metastases from estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER-2) negative breast cancer. Phase 1b was designed to select the recommended phase 2 dose (RP2D) and is followed by an ongoing phase 2 evaluation of elacestrant in combination with abemaciclib in participants with active brain metastases from ER-positive, HER-2 negative breast cancer.

Al Prediction of Sarcopenia Risk in Neurocritical ICU Patients

This prospective observational study aims to evaluate sarcopenia in intensive care patients with intracranial pathologies using ultrasound and to compare the predictive performance of different artificial intelligence models. Rectus femoris muscle thickness will be measured by ultrasound on ICU admission (Day 0) and Day 7. Prealbumin levels will be assessed on Days 0, 3, and 7, and the modified Nutrition Risk in Critically Ill (mNUTRIC) score will be calculated on the first day of ICU admission. Clinical, laboratory, and ultrasonographic data will be integrated into different artificial intelligence models to predict sarcopenia status on Day 7. The study aims to determine the effectiveness of artificial intelligence in the early identification of sarcopenia and to support future clinical decision-making in intensive care practice.

Preoperative Embolization for Highly Vascular Brain Tumors

Highly vascular brain tumors, including meningiomas, hemangioblastomas, and certain metastases, have a rich blood supply that can lead to substantial blood loss and technical difficulties during surgical removal. Preoperative endovascular embolization is an adjunctive, catheter-based procedure used to block the feeding blood vessels of the tumor before surgery, aiming to reduce intraoperative bleeding and facilitate safer tumor resection. The primary purpose of this study is to evaluate the technical feasibility, safety, and effectiveness of preoperative endovascular embolization in patients with highly vascular intracranial tumors. Participants enrolled in this prospective study will undergo: 1. Pre-procedural neurological and diagnostic cross-sectional imaging (contrast-enhanced MRI or CT angiography). 2. Diagnostic digital subtraction angiography (DSA) to map tumor-feeding arteries, followed by super-selective catheterization to deliver embolic materials (polyvinyl alcohol particles, Onyx, or microcoils). 3. Microsurgical tumor resection within 24 to 72 hours following the embolization procedure. Researchers will assess the degree of tumor devascularization achieved, the volume of intraoperative blood loss, blood transfusion requirements, total surgical duration, extent of tumor resection, and the occurrence of any procedure-related complications.

Susceptibility-Weighted Imaging in Preoperative Grading of Cerebral Gliomas

Gliomas are the most common primary brain tumors in adults. Determining whether a glioma is low-grade or high-grade before surgery is essential for surgical planning, choosing treatment pathways, and determining prognosis. Currently, definitive grading requires invasive tissue sampling through surgical resection or biopsy. Although conventional magnetic resonance imaging (MRI) is routinely performed, conventional sequences often show overlapping features between low-grade and high-grade tumors, limiting their ability to reliably predict tumor grade. Susceptibility-weighted imaging (SWI) is an advanced MRI sequence sensitive to microscopic magnetic field distortions caused by blood products, calcification, and abnormal tumor blood vessels. On SWI, these features appear as intratumoral susceptibility signals (ITSS). Because high-grade gliomas typically display greater vascular proliferation and microhemorrhages than low-grade gliomas, quantifying ITSS may provide a non-invasive surrogate for tumor grade. The primary purpose of this prospective observational study is to assess the diagnostic accuracy of SWI in the preoperative grading of cerebral gliomas, comparing imaging findings directly against histopathological examination according to the 2021 World Health Organization (WHO) Classification of Tumors of the Central Nervous System. Adult participants with radiologically suspected cerebral gliomas who are scheduled for surgical resection or stereotactic biopsy will undergo a standardized preoperative brain MRI protocol. This protocol incorporates SWI alongside conventional MRI sequences, diffusion-weighted imaging (DWI/ADC), and magnetic resonance spectroscopy (MRS). Two independent radiologists blinded to pathology will assess and grade intratumoral susceptibility signals. Following surgery, imaging-predicted grades will be compared with the final tissue pathology to determine the sensitivity, specificity, and overall diagnostic accuracy of SWI.

Ciprofol, Propofol and Sevoflurane for Postoperative Delirium in Elderly Brain Tumor Patients

This study will compare three anesthesia medicines used to put people into a deep sleep during surgery: ciprofol, propofol, and sevoflurane. All three are commonly used for general anesthesia, but they work in different ways. Ciprofol and propofol are given through a vein. Sevoflurane is breathed in as a gas. After brain tumor surgery, some older adults may develop sudden confusion and memory problems called delirium. Researchers want to learn which of these three medicines is best at preventing delirium and protecting brain function in older adults undergoing brain tumor surgery. About 381 participants aged 65 to 90 will take part. Participants will be randomly assigned to one of three groups. One group will receive ciprofol. Another group will receive propofol. The third group will receive sevoflurane. All participants will receive standard care during and after brain tumor removal. The main goal is to compare how many participants develop delirium within 7 days after surgery. Researchers will also look at how long delirium lasts, how severe it is, thinking and memory skills at 7, 30, 90, and 180 days after surgery, quality of recovery, blood pressure and heart rate during surgery, and treatment safety. Blood tests will be used to measure markers of body stress, inflammation, and nerve cell injury before surgery, 3 hours after surgery, and 1 day after surgery. Researchers will also test thinking and memory with simple questions twice a day for 7 days after surgery. Later follow-up will be done by phone at 30, 90, and 180 days after surgery. This study is designed to explore which anesthesia medicine is safest and best at protecting the brain after surgery in older adults with brain tumors. The results may help doctors choose the best anesthesia for this group of patients in the future.

A Study to Learn About the Study Medicine Called PF-07799544 as Monotherapy or in Combination in People With Advanced Solid Tumors

The purpose of this clinical trial is to learn the safety and effects of the study medicine (PF-07799544) alone or in combination as a potential cancer treatment for adults with advanced solid tumors. The study will be conducted in two parts: PF-07799544 as a single agent (Phase 1a) and PF-07799544 in combination with another study medicine called PF-07799933 (Phase 1b). Phase 1a is no longer open for enrollment. In Phase1b (noted as "this study"), we are seeking participants who have: * a solid tumor which is metastatic or recurrent (excluding colorectal cancer) * tumor with the mutation (abnormal gene) called "BRAF V600" * received required prior treatment for cancer per cohort assigned. All participants in this study will receive both study medicines. Both study medicines are tablets that are taken by mouth at home twice a day. Participants will receive study medicines until their cancer is no longer responding, unacceptable side effects, or 2 years. Participants may continue to receive study therapy beyond 2 years. We will examine the experiences of people receiving the study medicines. This will help us determine if the study medicines are safe and effective.

BRAINFUL (BRAIN Tumor Focused Ultrasound-enabled Liquid Biopsy) Trial

Background: Accessing brain tumor material for pathological diagnosis requires invasive procedures that carry risk to patients including brain hemorrhages and death. Liquid biopsies are emerging non-invasive alternatives to direct tumour biopsies but the abundance of circulating tumor DNA (ctDNA) is relatively low and this limits our ability to accurately make the molecular diagnosis of brain tumors. We have recently shown promising results that suggest that the analysis of blood samples can distinguish brain tumor types. We now want to couple liquid biopsies with high intensity focused ultrasound (HIFU) to enhance the release of tumor DNA into the circulation and increase the sensitivity/and specificity of liquid biopsies for brain tumors. The aim of this project is to build on our preliminary findings and investigate the the time dependent changes associated with HIFU of a tumor to see if it improves accuracy of diagnosis and specifically molecular subtyping of tumors based on peripheral blood and cerebrospinal fluid (CSF) circulating tumor derived markers following HIFU.

Assessment of Endocrine and Metabolic Late Effects After Childhood Brain Tumor Treatment

This prospective, single-group interventional study evaluates endocrine and metabolic late effects in survivors of primary brain tumors treated during childhood. According to the study protocol, participants were prospectively assigned to undergo the Study-Specific Endocrine and Metabolic Late-Effects Assessment. The assessment included anthropometric measurements, repeated blood pressure measurements, clinical endocrine evaluation, fasting laboratory testing, and protocol-defined bone and vascular assessments. The purpose of the study was to identify the frequency and severity of endocrine and metabolic late effects and to evaluate their associations with tumor characteristics, previous cancer treatment, age at diagnosis, and physical functioning.

Ommaya Reservoir Placement at the Time of Biopsy for Longitudinal Biomarker Collection in Patients With Brain Tumors

This observational trial evaluates the use of Ommaya reservoir placed during a biopsy to collect biomarkers longitudinally in patients with brain tumor. A biomarker is a measurable indicator of the severity or presence of the disease state. An Ommaya reservoir is a small device that's implanted under the scalp. It allows the doctor to take samples of cerebrospinal fluid (CSF) in the future without doing a spinal tap. The identification of biomarkers in CSF is rapidly emerging as a promising minimally invasive approach for monitoring tumor growth and response to therapy. In the future, these biomarkers may be used to help determine what treatments could be most effective and how well a tumor has responded to prior therapy. Currently, limited long-term access to CSF has made it difficult for studies to learn if collecting CSF at different points in the treatment process is useful. Having an Ommaya reservoir placed during a biopsy may allow for longitudinal biomarker collection in patients with brain tumor.

3D-ASL and TDD-MRI for True Progression and Pseudoprogression After Glioma Surgery

Background: Differentiating true progression (TP) from pseudoprogression (PsP) after glioma surgery remains a major clinical challenge because conventional magnetic resonance imaging (MRI) often cannot reliably distinguish these conditions. Objective: This prospective observational diagnostic accuracy study aims to evaluate the value of multiparametric imaging based on three-dimensional arterial spin labeling (3D-ASL) combined with time-dependent diffusion MRI (TDD-MRI) for differentiating TP from PsP in postoperative glioma patients. Methods: Consecutive adult patients with suspected tumor progression after glioma surgery will undergo routine MRI, 3D-ASL, and TDD-MRI examinations. Quantitative perfusion and diffusion parameters will be extracted, and a combined imaging model will be developed and evaluated. Final diagnosis will be established according to pathological findings when available or by longitudinal clinical and imaging follow-up based on the Response Assessment in Neuro-Oncology (RANO) criteria. Expected Outcomes: The primary outcome is the diagnostic performance of the combined imaging model, assessed by the area under the receiver operating characteristic curve (AUC). The study is expected to provide a noninvasive imaging strategy for distinguishing TP from PsP and to support clinical decision-making during postoperative follow-up.

CONNEctome-guided Navigation for Eloquent-area Tumor Surgery Trial

This study is designed for patients with brain tumors located in eloquent brain areas involved in language, motor, or major functional brain networks. The purpose of the study is to determine whether connectome-guided navigation-assisted microsurgical resection can better preserve neurological function after surgery than conventional tractography-guided surgery. Participants who meet the study criteria will be assigned to one of two surgical planning strategies. In the experimental group, patients will undergo preoperative diffusion tensor imaging and resting-state functional MRI for individualized brain network reconstruction, and these data will be integrated with intraoperative navigation and neurophysiological monitoring to guide the resection boundary. In the control group, surgery will be guided by conventional DTI tractography-assisted navigation. The main outcome is the rate of postoperative functional preservation. Other outcomes include extent of tumor resection, postoperative complications, time to neurological recovery, overall survival, and quality of life. Patients will be evaluated before surgery and followed after surgery with clinical examinations, neurological assessments, and MRI at prespecified time points.

Fast Brain MRI in Children With Suspected Brain Tumor

This study aims to assess the diagnostic performance of a new fast MRI sequence named Neuromix compared to routine clinical MRI for brain tumor in pediatric patients

[18F]FET PET for Characterization of Progressive or Recurrent Glioma From Treatment Related Changes

This study is designed to prospectively analyze \[18F\]FET PET image data obtained retrospectively in the routine clinical care of glioma patients. The study will analyse the data from participants with grade (1-4) glioma after primary treatment according to local clinical practice and with suspicion of progression/recurrence on magnetic resonance imaging (MRI).

MR Elastography in Intracranial Lesions: Feasibility & Accuracy

Brain tumors, despite their relatively low incidence among cancers, are associated with high morbidity and mortality due to the brain's complexity. Biopsy, the gold standard for tumor grading, is limited by invasiveness, costs, and sampling issues. Conventional MR imaging lacks sensitivity to differentiating tumor grades, while magnetic resonance elastography (MRE) offers non-invasive assessment potential. This retrospective study reviewed MRE data from 626 brain tumor patients (May 2017-September 2025) to evaluate MRE's diagnostic performance, success rate in tumor grading, and clinical reliability, aiming to advance its role in non-invasive brain tumor assessment.

Guided Meditation During Radiation Therapy for Brain Tumors

The goal of this interventional treatment study is to assess the anxiolytic effect of providing guided meditation during radiation treatment (RT) in patients with brain tumors. The main question it aims to answer is: • What is the change in acute anxiety in participants receiving the mindfulness intervention during radiation therapy compared to standard of care control conditions? Participants will be asked to participate in a 5-minute, audio-recorded mindfulness practice that will be played during the administration of each RT session. Researchers will compare this intervention to standard of care (no intervention) during RT.

OT SMILE: Occupational Therapy Group Intervention for Primary Brain Tumour Patients

People diagnosed with primary brain tumours often experience significant symptoms such as fatigue, cognitive changes, anxiety, and reduced ability to carry out everyday activities. These symptoms may be related to the tumour itself or to ongoing systemic anti-cancer treatment. In Ireland, access to structured rehabilitation and symptom management programmes for this population is limited. The OT SMILE study is evaluating whether a structured occupational therapy-led group programme can improve quality of life and daily functioning in adults with primary brain tumours receiving active treatment. Participants attending Beaumont Hospital who meet eligibility criteria and provide informed consent will be randomly assigned (like flipping a coin) to one of two groups: A six-week occupational therapy group programme (OT SMILE), or Usual care, consisting of written lifestyle management information. The OT SMILE programme consists of six weekly 90-minute group sessions delivered by occupational therapists. Sessions focus on fatigue management, activity modification, cognitive strategies, relaxation techniques, goal setting, exercise, nutrition, and peer support. Participants in both groups will complete questionnaires before the programme begins and again after six weeks. These questionnaires measure quality of life, fatigue, and daily functioning. The main goal of the study is to determine whether the occupational therapy group programme improves health-related quality of life compared to usual care. The results may help inform supportive care services for people living with primary brain tumours.

Detection of Brain Metastases Using a Novel Gadolinium-Weighted MRI Sequence: A Prospective Comparison

This study will evaluate a new type of MRI sequence designed to improve the visibility of brain metastases after gadolinium contrast injection. The purpose is to determine whether this novel "gadolinium-weighted" imaging method can detect more or smaller tumors than standard MRI techniques. Participants will undergo a routine brain MRI with contrast, followed by an additional scan using the new method. The goal is to improve diagnostic accuracy without increasing the contrast dose or scan time.

Platelets Activation in Brain Neoplasms

Platelets are primarily known for their central role in primary hemostasis. However, they are increasingly recognized for their participation in various non-hemostatic processes, such as cancer progression and clinical expression. Experimental and clinical data indicate that the involvement of platelets in the pathophysiology of cancer goes far beyond the realm of cancer-associated thrombosis. Several experimental studies have shown that platelets can promote the metastatic process by various mechanisms. However, while it has been shown in vitro that direct contact with platelets initiates tumor cells for metastasis, it remains unclear whether such contacts occur in solid tumors. In addition to their ability to promote metastasis, platelets have been shown to stimulate angiogenesis and play a crucial role in lymphangiogenesis. Considering that blood vessels, lymphatics and immune cells are major components of the tumor ecosystem, our hypothesis is that platelets contribute to the development and / or regulation of the tumor microenvironment. This is because platelets stabilize tumor blood vessels by permanently repairing vascular damage caused by immune cells infiltrating tumors. Targeting platelets destabilizes tumor vessels, causing intra-tumor hemorrhage, which allows intra-tumor accumulation of intravenously administered anti-tumor drugs such as paclitaxel and improves their efficacy. Studies have also reported the role of platelets in several pathogenic mechanisms of cancer: thrombocytosis is a paraneoplastic syndrome which suggests a poor prognosis in patients with solid tumors; a negative correlation between the platelet count and the response to chemotherapy has been reported in several types of cancer; histological analyzes of esophageal cancer suggested a possible association between the presence of platelets in the tumor stroma and the level of tumor lymphangiogenesis and lymphovascular invasion; finally, a recent study reported the expression of one of the main targets of immunotherapies, PD-L1, on the platelets of patients suffering from different types of solid cancers. All of these data support our hypothesis that platelets are components and / or regulators of the tumor microenvironment and therefore potential targets for the improvement of anti-tumor therapies. In this context, the objectives of our project are to determine whether platelets are components of the microenvironment of tumors of the central nervous system, and to study the possible correlations between the intratumoral presence of platelets and the evolution of patients with central nervous system tumors

DETERMINE Trial Treatment Arm 03: Entrectinib in Adult, Paediatric and Teenage/Young Adult Patients With ROS1 Gene Fusion-Positive Cancers.

This clinical trial is looking at a drug called entrectinib. Entrectinib is approved as standard of care treatment for adult patients with non-small cell lung cancer (NSCLC) which have a particular molecular alteration called ROS1-positive, and patients 12 years old or above with solid tumours which have another type of change in the cancer cells. This means it has gone through clinical trials and been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Investigators now wish to find out if it will be useful in treating patients with other cancer types which have the same molecular alteration (ROS1-positive). If the results are positive, the study team will work with the NHS and the Cancer Drugs Fund to see if these drugs can be routinely accessed for patients in the future. This trial is part of a trial programme called DETERMINE. The programme will also look at other anti-cancer drugs in the same way, through matching the drug to rare cancer types or ones with specific mutations.

HOBSCOTCH-CA (HOme-Based Self-management and COgnitive Training CHanges Lives in Brain CAncer)

The purpose of this study is to assess the ability of the home-based intervention, HOBSCOTCH-CA, to improve the quality of life and cognitive function in Service Members, Veterans and civilians who are survivors of brain cancer or a brain tumor (CA participants). This study will also assess the ability of the HOBSCOTCH-CA program to improve quality of life in caregivers of patients with brain cancer/tumor and to reduce caregiver burden. Enrolling with a Caregiver is optional for CA participants. Investigators will compare two groups of CA participants and their Caregiver (enrolling with a Caregiver is optional): one who receives HOBSCOCTCH-CA immediately (Group 1) and another group that will receive HOBSCOTCH-CA (Group 2) after a 3-month waiting period. Participants will be in the study for about 6 months total. HOBSCOTCH-CA involves 45 to 60 minute one on one virtual sessions with a certified Cognitive Coach including a "pre" program session and 8 weekly sessions thereafter. Participants will learn about problem solving therapy and mindfulness or relaxation training. CA participants are asked to do short homework assignments and keep a brief daily diary on a smart phone app. All participants complete study questionnaires or surveys at enrollment, 3 months later and at 6 months (at the end of the study).

Intraoperative Fluorescence-Guided Aspirate Tissue Monitoring of 5-ALA During Brain Tumor Surgery

Gliomas are tumors that occur in all ages; they include the most common malign primary central nervous system tumors in developed countries. Gliomas are often aggressive, and their recommended treatment is surgical resection and chemoradiation. Complete tumor removal is challenging because of diffuse cell growth and the proximity of functionally critical tissues. The current golden standard for intraoperative glioma detection is fluorescence-guided surgery (FGS) using 5-ALA. In 5-ALA FGS the drug-induced fluorescence helps to visually detect tumor cells, which improves resection rates and delays tumor progression. Tumor cells are often left unnoticed because of visual obstacles or weak fluorescence, which may lead to local recurrence and reoperations. Surgical suction devices are routinely used to remove cancerous tissues, but so far, the analysis of the suction waste has not been used in near real-time tissue detection.