Using fluorescence imaging and light therapy to improve surgery outcomes for advanced colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of fluorescence image-guided surgery followed by intraoperative photodynamic therapy (PDT) in patients with locally advanced or recurrent colorectal cancer. The approach involves administering a photosensitizing agent, aminolevulinic acid, which helps surgeons visualize cancerous tissues during surgery. After the surgery, PDT is applied to target any remaining cancer cells. The study aims to assess the safety, accuracy, and potential efficacy of this combined treatment method.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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
* Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

* 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
* Patients with any acute hepatitis or chronic liver dysfunction with baseline elevated liver function tests (i.e. Aspartate transaminase (AST)/alanine transaminase (ALT) ≥ 2.5 x upper limit of normal \[ULN\]) will be excluded from the study
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Patients unwilling or unable to follow protocol requirements
* Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug and/or procedure

Where it's running

• Roswell Park Cancer Institute
  Buffalo, New York, United States Recruiting

Study contacts

• Principal investigator: Anthony S Dakwar — Roswell Park Cancer Institute

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.