\*As of June 2026- Phase I has been completed and we are now in Phase II. 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.
Age ≥ 18 years of age
Patients with locally advanced or recurrent colorectal cancer undergoing surgery
Amenable to diagnostic CT and MR imaging
Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 3
Pregnant or nursing female participants
Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive the fluorescence-guided surgery with intraoperative PDT
Patients with porphyria, or with known hypersensitivity to porphyrins or porphyrin-like compounds
Patients who are not cleared to undergo surgery
Single group
Aminolevulinic Acid
DrugGiven PO
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Computed Tomography
Procedure/SurgeryUndergo CT
Fluorescence-Guided Surgery
Procedure/SurgeryUndergo fluorescence-guided surgery
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Photodynamic Therapy
DrugUndergo PDT
Surgical Procedure
Procedure/SurgeryUndergo surgery
Accuracy of the fluorescence imaging (Phase I)
Will be determined by histopathology by examining the number of true positive fluorescence cases out of the total positive fluorescence biopsies collected in the study. This will be determined by reviewing the pathology reports. The proportion of surgical cases exhibiting a positive fluorescence signal by utilizing a simple proportion along with a 95% confidence interval.
Incidence of adverse events (Phase I)
Will be measured by recording Gleolan administration and intraoperative photodynamic therapy (PDT) treatment related adverse events that are ≥ grade 3 with attribution of 'probable', or 'definite', according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0, that do not resolve within 7 days.
Evidence of disease (Phase II)
Will be assessed by standard-of-care computed tomography (CT) and/or magnetic resonance imaging (MRI). The recurrence proportion and exact 95% confidence interval will be calculated.
Changes in carcinoembryonic antigen (CEA) and circulating tumor deoxyribonucleic acid (ctDNA) (Phase II)
Will be evaluated by collecting peripheral blood samples. The mean and a 95% confidence interval will be calculated around the mean change from baseline.
Changes in CEA and ctDNA (Phase I)
Will be evaluated by collecting peripheral blood samples. The mean and a 95% confidence interval will be calculated around the mean change from baseline.
Rate of recurrence (Phase I)
Will be evaluated with standard-of-care CT and/or MRI to detect evidence of disease. The recurrence proportion and exact 95% confidence interval will be calculated.
Rate of local recurrence (Phase II)
Will be assessed by standard-of-care CT and/or MRI. The recurrence proportion and exact 95% confidence interval will be calculated.
Disease free survival (Phase II)
Will be detected via standard-of-care CT and/or MRI during the long-term follow-up that will be part of standard of care. The recurrence proportion and exact 95% confidence interval will be calculated.
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Roswell Park Cancer Institute
Lead sponsor
National Center for Advancing Translational Sciences (NCATS)
Collaborator
