Actively Recruiting
Image Guided Surgery Followed by Intraoperative Photodynamic Therapy for Improving Local Tumor Control in Patients With Loco-Regionally Advanced or Recurrent Colorectal Cancer Undergoing Surgery - Phase I/II
Led by Roswell Park Cancer Institute · Updated on 2026-06-05
21
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
R
Roswell Park Cancer Institute
Lead Sponsor
N
National Center for Advancing Translational Sciences (NCATS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a combined approach of fluorescence image guided surgery followed by intraoperative photodynamic therapy (PDT) to improve local tumor control in patients with locally advanced or recurrent colorectal cancer. This Phase I/II trial aims to study the side effects, safety, and potential benefits of this treatment method using a drug called aminolevulinic acid hydrochloride, which helps the surgeon see and target cancer cells more precisely. In this trial, patients take aminolevulinic acid orally 2 to 4 hours before their standard surgery. After the surgery, fluorescence imaging is performed to detect any remaining cancer cells. Then, within 15 to 45 minutes post-surgery, intraoperative photodynamic therapy is applied using red laser light to activate the drug and kill cancer cells. Patients also undergo CT or MRI scans during screening and follow-up, along with regular blood sample collections throughout the trial. Participants are followed up at 3 months, 24 weeks, and then every 3 to 6 months for up to 3 years after treatment. The study measures include the accuracy of fluorescence imaging, incidence of side effects, evidence of disease post-treatment, changes in blood markers like carcinoembryonic antigen (CEA) and circulating tumor DNA (ctDNA), as well as rates of recurrence and disease-free survival. Safety monitoring includes adverse event tracking up to 30 days post-therapy, with imaging and blood tests supporting ongoing assessment.
CONDITIONS
Brief Title
Fluorescence Image Guided Surgery Followed by Intraoperative Photodynamic Therapy for Improving Local Tumor Control in Patients With Locally Advanced or Recurrent Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with locally advanced or recurrent colorectal cancer and undergoing surgery
- Able to undergo diagnostic CT and MRI imaging
- Eastern Cooperative Oncology Group (ECOG) performance status of 3 or less
- Participants of child-bearing potential must agree to use adequate contraception
- Able to understand the study and provide signed informed consent
You will not qualify if you...
- Pregnant or nursing female participants
- Any condition deemed unsuitable by the Investigator for fluorescence-guided surgery with intraoperative PDT
- Patients with porphyria or known hypersensitivity to porphyrins or porphyrin-like compounds
- Patients not cleared to undergo surgery
- Acute hepatitis or chronic liver dysfunction with elevated liver enzymes (AST/ALT ≥ 2.5 x upper limit of normal)
- Uncontrolled illness such as active infection, symptomatic heart failure, unstable angina, arrhythmia, or psychiatric/social issues limiting compliance
- Unable or unwilling to follow protocol requirements
- Any condition deemed unsuitable by the Investigator to receive the study drug and/or procedure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) including CT or MRI imaging
Duration - Day of surgery
Participants receive aminolevulinic acid orally 2 to 4 hours prior to surgery. They then undergo fluorescence-guided surgery followed by intraoperative photodynamic therapy shortly after surgery.
1 surgical visit (in-person)
Duration - Up to 3 years after treatment
Participants have follow-up visits to monitor recovery and assess disease status through imaging and blood sample collection.
Follow-up visits at 3 months, 24 weeks, and every 3 to 6 months for up to 3 years
Trial Site Locations
Total: 1 location
1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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