Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 1 study, sponsored by Roswell Park Cancer Institute.
NCT06307548 is a Phase 1 study that is actively recruiting participants, run by Roswell Park Cancer Institute. The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Will be determined by histopathology by examining the number of true positive fluorescence cases out of the total positive fluorescence biopsies collected in the study. This will be determined by reviewing the pathology reports. The proportion of surgical cases exhibiting a positive fluorescence signal by utilizing a simple proportion along with a 95% confidence interval.
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 |
What NCT06307548 shows while recruiting
NCT06307548 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06307548 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06307548's enrollment target sits among peer trials
21 1615th of 2000 higher than 372 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02447874 · 21 participants · Phase 1
Arginine Therapy for the Treatment of Pain in Children With Sickle Cell Disease
- NCT03826992 · 21 participants · Phase 1
Venetoclax Combined With Vyxeos (CPX-351) for Participants With Relapsed or Refractory Acute Leukemia
- NCT04107077 · 21 participants · Phase 2
Phase II Study of the Effects of Laparoscopic Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Patients With Advanced Gastric Cancer
- NCT04158635 · 21 participants · Phase 1
Gemcitabine, Nab-Paclitaxel, and Bosentan for the Treatment of Unresectable Pancreatic Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI