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Photosensitizing Agent

Fluorescence-Guided Surgery and Photodynamic Therapy for Colorectal Cancer

Phase 1 & 2

Recruiting

Led By Anthony S Dakwar

Research Sponsored by Roswell Park Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study the use of a drug called aminolevulinic acid hydrochloride in combination with a special type of surgery called fluorescence image guided surgery followed by intraoperative photodynamic

Who is the study for?

This trial is for patients with colorectal cancer that has spread to nearby areas or returned after treatment. Participants should be suitable for surgery and photodynamic therapy, but specific inclusion and exclusion criteria are not provided.

What is being tested?

The study tests a two-step treatment: first, surgeons use a special drug (aminolevulinic acid) that makes cancer cells glow under blue light during surgery; then they apply red laser light to kill any remaining cancer cells using photodynamic therapy.

What are the potential side effects?

Potential side effects may include skin sensitivity to light due to the photosensitizing agent used in the procedure, as well as typical risks associated with surgical interventions and photodynamic therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Accuracy of the fluorescence imaging (Phase I)

Changes in carcinoembryonic antigen (CEA) and circulating tumor deoxyribonucleic acid (ctDNA) (Phase II)

Evidence of disease (Phase II)

+1 more

Secondary study objectives

Changes in CEA and ctDNA (Phase I)

Correlation between disease free survival and changes in levels of CEA (Phase II)

Correlation between disease free survival and changes in levels of ctDNA (Phase II)

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (aminolevulinic, fluorescence-guided surgery, PDT)Experimental Treatment7 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Surgical Procedure

2020

Completed Phase 2

~160

Photodynamic Therapy

2014

Completed Phase 4

~460