Clinical trial NCT06307548: Fluorescence Image Guided Surgery Followed by Intraoperative Photodynamic Therapy for Improving Local Tumor Control in Patients With Locally Advanced or Recurrent Colorectal Cancer
Official title: 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
Conditions: Locally Advanced Colorectal Carcinoma
Recurrent Colorectal Carcinoma
Stage III Colorectal Cancer
Summary: 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:
description: Given PO
name: Aminolevulinic Acid
other_name: 5-ALA
5-Aminolaevulinic Acid
5-Aminolevulinic Acid
Amino-Levulinic Acid
Delta Aminolevulinic Acid
Delta-Aminolevulinic Acid
type: Drug
description: Undergo blood sample collection
name: Biospecimen Collection
other_name: Biological Sample Collection
Biospecimen Collected
Specimen Collection
type: Procedure
description: Undergo CT
name: Computed Tomography
other_name: CAT
CAT Scan
CT
CT Scan
Computed Axial Tomography
Computerized Axial Tomography
Computerized Tomography
Computerized axial tomography (procedure)
tomography
type: Procedure
description: Undergo fluorescence-guided surgery
name: Fluorescence-Guided Surgery
other_name: Fluorescence-Guided Surgical Procedure
type: Procedure
description: Undergo MRI
name: Magnetic Resonance Imaging
other_name: MR
MR Imaging
MRI
MRI Scan
MRIs
Magnetic Resonance
Magnetic Resonance Imaging Scan
Magnetic resonance imaging (procedure)
Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
NMR Imaging
NMRI
Nuclear Magnetic Resonance Imaging
Structural MRI
sMRI
type: Procedure
description: Undergo PDT
name: Photodynamic Therapy
other_name: PDT
Photoradiation Therapy
type: Drug
description: Undergo surgery
name: Surgical Procedure
other_name: Operation
Surgery
Surgery Type
Surgery, NOS
Surgical
Surgical Intervention
Surgical Interventions
Surgical Procedures
Type of Surgery
type: Procedure
Study arms:
design_group_description: Patients receive aminolevulinic acid PO 2 to 4 hours prior to SOC surgery. Patients then undergo image-guided fluorescence 5-10 minutes post surgery, and intraoperative PDT 15-45 minutes post surgery. Patients also undergo CT or MRI during screening and on follow up. Patients also undergo blood sample collection throughout the trial.
design_group_title: Treatment (aminolevulinic, fluorescence-guided surgery, PDT)
design_group_type: Experimental
Sponsor: Roswell Park Comprehensive Cancer Center
Collaborators: National Center for Advancing Translational Sciences
Drug name mappings:
name: 盐酸氨酮戊酸
lang: CN
name: Aminolevulinic Acid Hydrochloride
lang: EN
name: アミノレブリン酸塩酸塩
lang: JP