Actively Recruiting
Fluorescence Image Guided Surgery Followed by Intraoperative Photodynamic Therapy for Improving Local Tumor Control in Patients With Locally Advanced or Recurrent Colorectal Cancer
Led by Roswell Park Cancer Institute · Updated on 2026-05-06
21
Participants Needed
1
Research Sites
148 weeks
Total Duration
On this page
Sponsors
R
Roswell Park Cancer Institute
Lead Sponsor
N
National Center for Advancing Translational Sciences (NCATS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Fluorescence Image Guided Surgery Followed by Intraoperative Photodynamic Therapy for Improving Local Tumor Control in Patients With Locally Advanced or Recurrent Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of locally advanced or recurrent colorectal cancer undergoing surgery
- Able to have diagnostic CT and MR imaging
- Eastern Cooperative Oncology Group (ECOG) performance status of 3 or less
- Participants of child-bearing potential must agree to use effective contraception before study entry
- Ability to understand the study and provide written informed consent
You will not qualify if you...
- Pregnant or nursing females
- Conditions making the participant unsuitable for fluorescence-guided surgery with intraoperative PDT as judged by the investigator
- Porphyria or known hypersensitivity to porphyrins or similar compounds
- Not cleared to undergo surgery
- Acute hepatitis or chronic liver dysfunction with elevated liver function tests (AST/ALT ≥ 2.5 times upper limit of normal)
- Uncontrolled illnesses such as active infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, or psychiatric/social issues limiting study compliance
- Unwillingness or inability to follow study requirements
- Any other condition deemed unsuitable by the investigator to receive study drug or procedure
AI-Screening
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Trial Site Locations
Total: 1 location
1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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