Clinical Research Directory

Surgical Margin Assessment Using Intra-operative High-resolution PET/CT in Patients With Cancers Referred to Surgical Resection, an Exploratory Pilot Study

Reoperation is often required in surgical oncology because of positive resection margins and is associated with substantial physical, psychological, and economic consequences. Reoperation may also alter or delay the initiation of adjuvant therapy, potentially increasing the risk of local or distant recurrence. When re-resection is not feasible, a positive resection margin may necessitate additional treatment (e.g., radiation therapy or chemotherapy) that might otherwise have been avoided if clear margins had been achieved during the initial operation. Moreover, obtaining a negative margin during reoperation does not necessarily result in improved oncologic outcomes. Therefore, achieving negative margins intraoperatively is a key objective in oncologic surgery. The AURA 10 Specimen PET/CT imaging system, a novel technology developed by a Belgian company, has recently been introduced to the market. This system enables perioperative imaging of resected tumors within approximately 10 minutes, allowing prompt assessment of surgical margins. Preliminary studies have demonstrated the potential clinical utility of this technique in various cancers, including breast, head and neck, and prostate cancers (1-5). A recent multicenter study of patients with breast cancer reported a sensitivity of 91% and a specificity of 86% for assessing surgical margin status in invasive ductal carcinoma (IDC) (4). The aim of this study is to evaluate the clinical utility of perioperative specimen PET/CT imaging for surgical margin assessment and the feasibility of implementing this technology in routine clinical practice. The study will initially focus on breast cancer, head and neck cancer, soft tissue sarcomas, lung cancer, colorectal liver metastases, and hepatobiliary and pancreatic malignancies. Patients will be screened for study eligibility. Those who meet the eligibility criteria will be invited to participate and provide written informed consent. On the day of the scheduled operation, patients will receive an injection of the FDG radiotracer in the Department of Nuclear Medicine approximately 1 hour before surgery. They will then be transfered by authorized personnel to the operating room. Immediately after tumor resection, the surgical specimen will be imaged using the specimen PET/CT imager (AURA 10, Xeos); this process will take approximately 10 minutes. If the surgeon decides to re-excise additional tissue, that tissue will also be imaged. In addition, all resected lymph nodes will be imaged for research purposes only. The specimen will then be transferred to the histopathology laboratory for standard-of-care evaluation. During the operation, the results of specimen PET/CT imaging will not influence the surgeon's intraoperative decision-making. Subsequent clinical decisions will be based on the results of standard-of-care evaluations and the treating physician's clinical judgment. The final surgical margin status, as determined by the pathologist, will be collected for study purposes. Patients will receive treatment and follow-up in accordance with the standard of care, and relevant follow-up data will be collected.

Hepatic Arterial Infusion Chemotherapy in Patients With Inoperable Colorectal Cancer Liver Metastasis

The goal of this clinical trial is to assess how many patients with initially inoperable colorectal liver metastasis are able to have a liver surgery after treatment with hepatic artery infusion chemotherapy and standard of care systemic chemotherapy.

Liver-First, Bowel-First, or Simultaneous Resection for Synchronous Colorectal Liver Metastases: Outcomes, Quality of Life, and Cost-Effectiveness

The goal of this observational study is to learn about treatment outcomes, quality of life, and healthcare costs in patients with colorectal cancer who have liver metastases detected at the same time as their primary tumor (synchronous colorectal liver metastases, CRLM). The main questions it aims to answer are: Do patients who undergo simultaneous removal of both the bowel tumor and liver metastases in one operation differ in their ability to complete the intended treatment compared to patients who undergo staged operations (bowel first or liver first)? Does the choice of surgical strategy affect quality of life and healthcare costs? Patients with synchronous CRLM discussed at a multidisciplinary team meeting at participating Swedish university hospitals will be followed prospectively for up to 5 years. Treatment is not influenced by the study - all surgical decisions are made as part of routine clinical care. Patients in the quality-of-life sub-study will complete validated questionnaires (EORTC QLQ-C30, QLQ-LM21, and QLQ-CR29) at multiple time points from diagnosis through 36 months. Healthcare costs and health literacy will also be assessed in parallel sub-studies.

Outcomes After Liver and Biliary Resection at a High-Volume Center

The goal of this observational study is to evaluate clinical and oncologic outcomes in adult patients undergoing liver and/or biliary resection for benign and malignant diseases. This study evaluates postoperative morbidity and mortality within 90 days after surgery, as well as overall survival and disease-free survival in patients with malignant disease. Participants will: * undergo standard surgical and perioperative management according to routine clinical practice * have clinical, surgical, and follow-up data collected from institutional medical records * be followed for postoperative outcomes and long-term oncologic outcomes up to 5 years

Sonoporation and Tumor Microenvironment Response in Colorectal Liver Metastases

This study is an investigator-initiated, randomized controlled trial enrolling patients with colorectal liver metastases. The objectives are to evaluate the safety and efficacy of contrast-enhanced ultrasound (CEUS)-mediated sonoporation as a potential therapeutic intervention and to investigate whether sonoporation can modulate the tumor microenvironment toward a more immune-active state

Prospective Cohort Study on the Relationship Between Exosomal Peroxiredoxin 1 (PRDX1) and Postoperative Liver Metastasis

The occurrence of liver metastasis after curative surgery for resectable colorectal cancer is an important cause of death for patients. Accurately identifying high-risk patients for metastasis and intervening in them has important clinical significance. The pathological examination of surgical specimens failed to fully utilize valuable specimen information and accurately predict liver metastasis; The biomarkers secreted by tumors are metabolized in the liver through the portal vein, especially the particles such as extracellular vesicles secreted by tumors, which are ultimately diluted in peripheral blood and cannot be effectively detected. Our research group extracted an average of 11.25ml of blood (named blood derived from portal vein branch specimens, sdBlood for short) from 8 colorectal cancer radical surgery specimens. Compared with peripheral blood, protein mass spectrometry analysis revealed a significant increase in exosome proteins such as peroxidized redox protein 1 (PRDX1), which are highly correlated with metastasis. This project innovatively uses sdBlood, which has been overlooked by routine pathological examination, to detect the exosomal protein PRDX1 in sdBlood, which is significantly higher than the peripheral blood concentration. A prospective cohort study was established, including 252 patients with pathologically confirmed colorectal cancer after radical surgery. The incidence and time of liver metastasis were followed up and observed. Cox regression statistical analysis was used to determine the correlation between this marker and metastasis and determine its critical value, providing a basis for clinical diagnosis and treatment.

The Role of the Imaging FAPI PET/CT in Exploring the Microenvironment of Colorectal Cancer Liver Metastases

FAPI PET/CT molecular imaging represents a cutting-edge advancement in oncological imaging, particularly for the preoperative assessment of colorectal liver metastases (CRLM). Fibroblast activation protein inhibitors (FAPIs), which are the focus of this imaging modality, selectively target cancer-associated fibroblasts, a critical component of the tumor microenvironment. FAPI PET/CT could be useful in the detection of HGP (Histological Growth Pattern) and in the changes during neoadjuvant chemotherapy prior to surgery