Recruiting
Phase 1
Phase 2

Fluorescence Image Guided Surgery

Sponsor:

Roswell Park Cancer Institute

Code:

NCT06307548

Conditions

Locally Advanced Colorectal Carcinoma

Recurrent Colorectal Carcinoma

Stage III Colorectal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Aminolevulinic Acid

Biospecimen Collection

Computed Tomography

Fluorescence-Guided Surgery

Magnetic Resonance Imaging

Study Details

Brief summary:

\*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.

Conditions

Locally Advanced Colorectal Carcinoma

Recurrent Colorectal Carcinoma

Stage III Colorectal Cancer

Study ID

NCT06307548

Start date

Jul 30, 2024

Status verified date

Jun, 2026

Completion date

Jun 1, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

21 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (aminolevulinic, fluorescence-guided surgery, PDT)

Patients receive aminolevulinic acid PO 2 to 4 hours prior to SOC surgery. Patients then undergo image-guided fluorescence 5-10 minutes post surgery, and intraoperative PDT 15-45 minutes post surgery. Patients also undergo CT or MRI during screening and on follow up. Patients also undergo blood sample collection throughout the trial.

Interventions

Aminolevulinic Acid

Given PO

Biospecimen Collection

Undergo blood sample collection

Computed Tomography

Undergo CT

Fluorescence-Guided Surgery

Undergo fluorescence-guided surgery

Magnetic Resonance Imaging

Undergo MRI

Photodynamic Therapy

Undergo PDT

Surgical Procedure

Undergo surgery

Primary outcome measure

  • Accuracy of the fluorescence imaging (Phase I) [ Time Frame: Up to 3 years ]
  • Incidence of adverse events (Phase I) [ Time Frame: Up to 30 days post-therapy ]
  • Evidence of disease (Phase II) [ Time Frame: At 12 weeks post treatment ]
  • Changes in carcinoembryonic antigen (CEA) and circulating tumor deoxyribonucleic acid (ctDNA) (Phase II) [ Time Frame: Within 4 weeks prior to surgical/PDT intervention and 4-6 weeks after treatment ]

Central Contacts and Locations

Locations

Roswell Park Cancer Institute

Recruiting

Buffalo, New York, United States, 14263

Contacts

Anthony S. Dakwar

716-845-5807Anthony.Dakwar@RoswellPark.org

Principal Investigator:

Anthony S. Dakwar

More Information

Sponsor

Roswell Park Cancer Institute

Last update posted

Jun 5, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Roswell Park Cancer Institute on 2026-06-05.