Back to search results

Fluorescence Image Guided Surgery for Colorectal Cancer

This study is testing a new way to improve local tumor control in patients with colorectal cancer that has spread to nearby tissue (locally advanced) or has returned after treatment (recurrent). It involves a drug called aminolevulinic acid, which is taken by mouth before surgery. This drug helps cancer cells glow red under a special light during surgery, allowing surgeons to see and remove more of the tumor. After surgery, a treatment called intraoperative photodynamic therapy (PDT) uses light to destroy any remaining cancer cells. The study is currently in Phase II, focusing on how well this treatment works. You may be able to join if you are 18 or older, have locally advanced or recurrent colorectal cancer, and are having surgery.

Study design
This is an interventional study with a planned enrollment of 21 participants. It is a Phase I/II trial, with Phase I already completed.
What's involved
Participants will take aminolevulinic acid before surgery, undergo fluorescence-guided surgery and intraoperative PDT, and have CT or MRI scans and blood draws throughout the trial.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed up at 3 months, 24 weeks, and every 3 to 6 months for 3 years after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06307548

Fluorescence Image Guided Surgery Followed by Intraoperative Photodynamic Therapy for Improving Local Tumor Control in Patients With Locally Advanced or Recurrent Colorectal Cancer

Recruiting
PHASE1Ages 18+InterventionalTreatment
Roswell Park Cancer Institute
~21 participants
Updated 2026-06-05 on ClinicalTrials.gov
What's tested:Aminolevulinic AcidBiospecimen CollectionComputed TomographyFluorescence-Guided SurgeryMagnetic Resonance ImagingPhotodynamic Therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Accuracy of the fluorescence imaging (Phase I)
Measured over Up to 3 years
+3 more outcomes measured

Conditions

Locally Advanced Colorectal Carcinoma
Recurrent Colorectal Carcinoma
Stage III Colorectal Cancer

Explore related trials

Colorectal Carcinoma

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Anthony S Dakwar · PRINCIPAL_INVESTIGATOR · Roswell Park Cancer Institute

Who to contact

Anthony S. Dakwar
[email protected]
716-845-5807
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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

What this trial measures

  • Accuracy of the fluorescence imaging (Phase I)Up to 3 years

    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)Up to 30 days post-therapy

    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)At 12 weeks post treatment

    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)Within 4 weeks prior to surgical/PDT intervention and 4-6 weeks after treatment

    Will be evaluated by collecting peripheral blood samples. The mean and a 95% confidence interval will be calculated around the mean change from baseline.