nctId: NCT06307548 id: I-3670923 id: NCI-2024-01256 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: I-3670923 type: OTHER domain: Roswell Park Cancer Institute id: UL1TR001412 type: NIH link: https://reporter.nih.gov/quickSearch/UL1TR001412 briefTitle: Fluorescence Image Guided Surgery Followed by Intraoperative Photodynamic Therapy for Improving Local Tumor Control in Patients With Locally Advanced or Recurrent Colorectal Cancer overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2027-06-01 date: 2027-06-01 date: 2024-03-13 date: 2024-04-24 name: Roswell Park Cancer Institute class: OTHER name: National Center for Advancing Translational Sciences (NCATS) briefSummary: This phase I/II trial studies the side effects and how well fluorescence image guided surgery followed by intraoperative photodynamic therapy for improving local tumor control in patients with colorectal cancer that has spread to nearby tissue or lymph nodes (locally advanced) or that has come back after a period of improvement (recurrent). Fluorescence image guided surgery uses a drug named aminolevulinic acid hydrochloride. Aminolevulinic acid hydrochloride is a photosensitizing agent, meaning that is activated by light and, is converted to another drug in cancer cells more than in normal cells. The converted drug emits fluorescence red light when activated with low power blue light. It is used to assist the surgeon to see cancer cells and small cancerous tissue that may have been missed during routine surgery. In addition to emitting fluorescence light, the converted drug in the cancer cells and tissue can be activated with red laser light to kill cancer cells. This procedure is called photodynamic therapy (PDT). Performing fluorescence image guided surgery followed by intraoperative photodynamic therapy after the surgical removal of the colorectal tumor before the surgical site will be closed may be effective and improve outcomes in patients with locally advanced or recurrent colorectal cancer. conditions: Locally Advanced Colorectal Carcinoma conditions: Recurrent Colorectal Carcinoma conditions: Stage III Colorectal Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 21 type: ESTIMATED name: Aminolevulinic Acid name: Biospecimen Collection name: Computed Tomography name: Fluorescence-Guided Surgery name: Magnetic Resonance Imaging name: Photodynamic Therapy name: Surgical Procedure measure: Accuracy of the fluorescence imaging (Phase I) measure: Incidence of adverse events (Phase I) measure: Evidence of disease (Phase II) measure: Changes in carcinoembryonic antigen (CEA) and circulating tumor deoxyribonucleic acid (ctDNA) (Phase II) measure: Changes in CEA and ctDNA (Phase I) measure: Rate of recurrence (Phase I) measure: Rate of local recurrence (Phase II) measure: Disease free survival (Phase II) measure: Correlation between disease free survival and changes in levels of CEA (Phase II) measure: Correlation between disease free survival and changes in levels of ctDNA (Phase II) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Roswell Park Cancer Institute city: Buffalo state: New York zip: 14263 country: United States name: Anthony S. Dakwar role: CONTACT phone: 716-845-5807 email: Anthony.Dakwar@RoswellPark.org name: Anthony S. Dakwar role: PRINCIPAL_INVESTIGATOR lat: 42.88645 lon: -78.87837 hasResults: False