Fluorescence Image Guided Surgery and Photodynamic Therapy for Better Tumor Control in Advanced or Returning Colorectal Cancer

Program Overview

This clinical trial is exploring a new method to improve surgery for colorectal cancer that has spread nearby or returned after treatment. The method uses a drug called aminolevulinic acid hydrochloride, which makes cancer cells glow under a special light, helping surgeons see and remove them more accurately. After surgery, the glowing cells are treated with a red laser light to kill any remaining cancer cells, a process known as photodynamic therapy (PDT). This approach aims to improve outcomes for patients with advanced or recurrent colorectal cancer.

Description

PRIMARY OBJECTIVES:

• To test how well the glowing technique helps find leftover cancer cells during surgery. (Phase I)
• To check the safety of using laser light treatment after surgery in patients with advanced or returning colorectal cancer. (Phase I)
• To see if the laser light treatment is effective after using the glowing technique in surgery. (Phase II)

SECONDARY OBJECTIVES:

• To study the link between cancer-free survival and changes in certain blood markers. (Phase II)
• To track cancer recurrence using standard imaging tests like CT or MRI. (Phase II)

OUTLINE:

Patients will take aminolevulinic acid by mouth 2 to 4 hours before their usual surgery. After surgery, doctors will use the glowing technique to check for cancer cells, followed by laser light treatment. Patients will also have CT or MRI scans and give blood samples during the study.

After treatment, patients will have follow-up visits at 3 months, 24 weeks, and every 3 to 6 months for 3 years.

Eligibility Criteria