Using fluorescence imaging and light therapy to improve surgery outcomes for advanced colorectal cancer
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
This study is testing if using special light to help surgeons see cancer better during surgery, followed by light therapy to kill leftover cancer cells, can improve outcomes for people with advanced colorectal cancer.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 21 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Roswell Park Cancer Institute Academic / other |
| Locations | 1 site (Buffalo, New York) |
| Trial ID | NCT06307548 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of fluorescence image-guided surgery followed by intraoperative photodynamic therapy (PDT) in patients with locally advanced or recurrent colorectal cancer. The approach involves administering a photosensitizing agent, aminolevulinic acid, which helps surgeons visualize cancerous tissues during surgery. After the surgery, PDT is applied to target any remaining cancer cells. The study aims to assess the safety, accuracy, and potential efficacy of this combined treatment method.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with locally advanced or recurrent colorectal cancer who are undergoing surgery.
Not a fit: Patients who are pregnant, nursing, or have conditions that make them unsuitable for the procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve local tumor control and reduce recurrence rates in patients with advanced colorectal cancer.
How similar studies have performed: While the use of fluorescence imaging in surgery is established, the specific combination with intraoperative PDT for colorectal cancer is a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Buffalo, New York
- Roswell Park Cancer Institute — Buffalo, New York, United States (Recruiting)
Study contacts
- Principal investigator: Anthony S Dakwar — Roswell Park Cancer Institute
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.