Roswell Park Cancer Institute
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.
Locally Advanced Colorectal Carcinoma
Recurrent Colorectal Carcinoma
Stage III Colorectal Cancer
Aminolevulinic Acid
Biospecimen Collection
Computed Tomography
Fluorescence-Guided Surgery
Magnetic Resonance Imaging
Photodynamic Therapy
Surgical Procedure
PHASE1
PHASE2
PRIMARY OBJECTIVES: * To test the accuracy of image-guided fluorescence to detect residual disease. (Phase I) * To determine the safety of intraoperative PDT after fluorescence-guided surgery in patients with loco-regionally advanced or recurrent colorectal cancer undergoing surgery. (Phase I) * To determine the potential efficacy of intraoperative PDT (after image-guided fluorescence surgery). (Phase II) SECONDARY OBJECTIVES: * To assess the relationship between disease free survival and changes in levels of carcinoembryonic antigen (CEA) and circulating tumor DNA (ctDNA). (Phase II) * To assess rate of recurrence by using standard-of-care computed tomography (CT) and/or magnetic resonance imaging (MRI). (Phase II) OUTLINE: Patients receive aminolevulinic acid orally (PO) 2 to 4 hours prior to standard of care (SOC) surgery. Patients then undergo image-guided fluorescence 5-10 minutes post surgery, and intraoperative PDT 15-45 minutes post surgery. Patients also undergo computed tomography (CT) or magnetic resonance imaging (MRI) during screening and on follow up. Patients also undergo blood sample collection throughout the trial. After completion of study treatment, patients are followed up at 3 months, 24 weeks, and every 3 to 6 months for 3 years.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 21 participants |
| Masking : | NONE |
| Primary Purpose : | TREATMENT |
| Official Title : | Image Guided Surgery Followed by Intraoperative Photodynamic Therapy for Improving Local Tumor Control in Patients With Loco-Regionally Advanced or Recurrent Colorectal Cancer Undergoing Surgery - Phase I/II |
| Actual Study Start Date : | 2024-07-30 |
| Estimated Primary Completion Date : | 2027-06-01 |
| Estimated Study Completion Date : | 2027-06-01 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263