protocolSection identificationModule nctId: NCT06307548, orgStudyIdInfo id: I-3670923, secondaryIdInfos id: NCI-2024-01256, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: I-3670923, type: OTHER, domain: Roswell Park Cancer Institute, secondaryIdInfos 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, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2027-06-01, completionDateStruct date: 2027-06-01, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Roswell Park Cancer Institute, class: OTHER, collaborators name: National Center for Advancing Translational Sciences (NCATS), descriptionModule 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., conditionsModule conditions: Locally Advanced Colorectal Carcinoma, conditions: Recurrent Colorectal Carcinoma, conditions: Stage III Colorectal Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 21, type: ESTIMATED, armsInterventionsModule interventions name: Aminolevulinic Acid, interventions name: Biospecimen Collection, interventions name: Computed Tomography, interventions name: Fluorescence-Guided Surgery, interventions name: Magnetic Resonance Imaging, interventions name: Photodynamic Therapy, interventions name: Surgical Procedure, outcomesModule primaryOutcomes measure: Accuracy of the fluorescence imaging (Phase I), primaryOutcomes measure: Incidence of adverse events (Phase I), primaryOutcomes measure: Evidence of disease (Phase II), primaryOutcomes measure: Changes in carcinoembryonic antigen (CEA) and circulating tumor deoxyribonucleic acid (ctDNA) (Phase II), secondaryOutcomes measure: Changes in CEA and ctDNA (Phase I), secondaryOutcomes measure: Rate of recurrence (Phase I), secondaryOutcomes measure: Rate of local recurrence (Phase II), secondaryOutcomes measure: Disease free survival (Phase II), secondaryOutcomes measure: Correlation between disease free survival and changes in levels of CEA (Phase II), secondaryOutcomes measure: Correlation between disease free survival and changes in levels of ctDNA (Phase II), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Roswell Park Cancer Institute, city: Buffalo, state: New York, zip: 14263, country: United States, contacts name: Anthony S. Dakwar, role: CONTACT, phone: 716-845-5807, email: Anthony.Dakwar@RoswellPark.org, contacts name: Anthony S. Dakwar, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.88645, lon: -78.87837, hasResults: False