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Fluorescence Image Guided Surgery Followed by Intraoperative Photodynamic Therapy for Improving Local Tumor Control in Patients With Locally Advanced or Recurrent Colorectal Cancer

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years later Jun 1, 2027 → Jun 1, 2029
See other at-risk trials from Roswell Park Cancer Institute

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary and study completion pushed from Jun 1, 2027 to Jun 1, 2029
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: details revised at 4 of 6 entries
    • Study description expanded, about 11 words
  2. Minor Study description expanded, about 5 wordsv11
  3. Notable Trial status: Suspended to Recruiting
    • Site details revised
    v10
  4. Stopped Trial status: Recruiting to Suspended Sponsor's reason: drug shortage
    • Site details revised
    v9
  5. Minor Re-verified, no change to tracked fieldsv8
Show 6 earlier versionsHide 6 earlier versions
  1. Minor Start date changed from estimate of Aug 1, 2024 to Jul 30, 2024v7
  2. Notable Start date: Jun 1, 2024 to Aug 1, 2024v6
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study description shortened, about 20 words
    • Site details revised
    v5
  4. Minor Re-verified, no change to tracked fieldsv4
  5. Notable Start date: Apr 1, 2024 to Jun 1, 2024
    • Primary and study completion dates: Apr 1, 2027 to Jun 1, 2027
    v3
  6. Minor Re-verified, no change to tracked fieldsv2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
\*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.
Trial Details
NCT Number NCT06307548
Lead Sponsor Roswell Park Cancer Institute
Collaborators: National Center for Advancing Translational Sciences (NCATS)
Conditions
(from sponsor)
Locally Advanced Colorectal Carcinoma, Recurrent Colorectal Carcinoma, Stage III Colorectal Cancer
Related terms Colorectal Neoplasms
Enrollment 21 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov