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NCT06307548 · ClinicalTrials.gov registry record · Phase 1
Fluorescence Image Guided Surgery Followed by Intraoperative Photodynamic Therapy for Improving Local Tumor Control in Patients With Locally Advanced or Recurrent Colorectal Cancer
A Phase 1 study, sponsored by Roswell Park Cancer Institute.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
NCT06307548 is a Phase 1 study that is actively recruiting participants, run by Roswell Park Cancer Institute. The registered enrollment target is 21 participants.
The verdict
NCT06307548, a Phase 1 study, is actively recruiting participants, sponsored by Roswell Park Cancer Institute.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
Study Summary
\*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.
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- PROCEDURE Fluorescence-Guided Surgery
- DRUG Aminolevulinic Acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2024-07-30 |
| Est. Completion | 2027-06-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06307548
The ClinicalTrials.gov registry entry for NCT06307548 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Roswell Park Cancer Institute, which has 365 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06307548 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06307548 about?
NCT06307548 is a clinical study titled "Fluorescence Image Guided Surgery Followed by Intraoperative Photodynamic Therapy for Improving Local Tumor Control in Patients With Locally Advanced or Recurrent Colorectal Cancer". \*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...
What is the current status of trial NCT06307548?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2024-07-30. Estimated completion is 2027-06-01.
What interventions are being tested in trial NCT06307548?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Fluorescence-Guided Surgery (PROCEDURE), Aminolevulinic Acid (DRUG).
Who is sponsoring clinical trial NCT06307548?
This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.
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