Clinical Research Directory

5-Aminolevulinic Acid for Photodynamic Diagnosis of Malignant Glioma

This phase III, multicenter, open-label, single-arm study will evaluate the ability of 5-aminolevulinic acid hydrochloride (5-ALA HCl) powder for oral solution to visualize malignant tissue during surgery, and its safety, in adults with suspected or confirmed malignant high-grade glioma (WHO grade 3 or 4). Participants will receive oral 5-ALA HCl before surgery. The primary assessments will determine the proportion of biopsy specimens containing tumor cells in strongly and weakly fluorescent regions, evaluated separately using central histopathology. Secondary assessments will include postoperative residual tumor on MRI, participant-level positive predictive values, histopathological findings in nonfluorescent regions, and safety.

Sentinel Node and Organ-sparing Surgery in Stage I Colon Carcinoma

The aim of this study is to reduce the need for colectomy and its' associated morbidity and mortality in patients with pT1-2 colon carcinoma after endoscopic resection and an estimated lymph node metastasis (LNM) risk of \>15%, or with macroscopically suspected T1 tumors, by performing an endoscopic-assisted laparoscopic/robotic wedge resection of the tumor or scar, along with sentinel node (SLN) biopsy using indocyanine green (ICG). This intervention will be compared to the standard-of-care segmental resection using a partially randomized patient preference design. The primary outcome is the 3-year recurrence rate.