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

Part of paid clinical trials in Buffalo, New York.

Sponsor
Roswell Park Cancer Institute
Study ID
NCT06307548
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Locally Advanced Colorectal Carcinoma
  • Recurrent Colorectal Carcinoma
  • Stage III Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Aminolevulinic Acid — DRUG
    Given PO
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Fluorescence-Guided Surgery — PROCEDURE
    Undergo fluorescence-guided surgery
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Photodynamic Therapy — DRUG
    Undergo PDT
  • Surgical Procedure — PROCEDURE
    Undergo surgery

Study Details

\*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.

Key Dates

Start date
Jul 30, 2024
Status verified
Jun 2026
Primary completion
Jun 1, 2027
Completion
Jun 1, 2027

Study Design

Enrollment
21 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Accuracy of the fluorescence imaging (Phase I) [ Time Frame: Up to 3 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Roswell Park Cancer InstituteBuffaloNew York14263
Anthony S. Dakwar
[email protected]
716-845-5807
Anthony S. Dakwar (PRINCIPAL_INVESTIGATOR)

Find similar trials in Buffalo, NY

By research site
Roswell Park Cancer Institute· Buffalo, NY

Related Studies