Recruiting nowPhase 2
What this trial is trying to do
The researchers are testing whether aminolevulinic acid can make colorectal cancer cells easier to see under blue light during surgery, because cancer cells convert it into a fluorescent, light-sensitive compound more than normal cells do. After removing the visible tumour, red laser light is used to activate that compound in the surgical area and kill cancer cells that may remain.
The idea is that seeing small areas of cancer more clearly, followed by photodynamic therapy, could improve local tumour control compared with surgery alone. The trial is measuring fluorescence-imaging accuracy in its initial phase and treatment side effects; it does not establish whether patients live longer or remain free of cancer for longer.
Worth knowing: This is a small, non-randomised phase I/II trial, so it has no surgery-only comparison group and cannot show that the approach improves outcomes.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT06307548 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | open label |
| Taking part | 21 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Roswell Park Cancer Institute |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug Aminolevulinic Acid
- Procedure Biospecimen Collection
- Procedure Computed Tomography
- Procedure Fluorescence-Guided Surgery
- Procedure Magnetic Resonance Imaging
- Drug Photodynamic Therapy
- Procedure Surgical Procedure
What it is measuring
Accuracy of the fluorescence imaging (Phase I)
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Phase 2. Tests whether the treatment works well enough to be worth a larger trial. Usually too small to prove it changes survival.
How the researchers describe it
*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.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Locally advanced
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
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.
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 1 site. Listed in: United States.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT06307548, registered by Roswell Park Cancer Institute on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.