Trial Title:
Fluorescence Image Guided Surgery Followed by Intraoperative Photodynamic Therapy for Improving Local Tumor Control in Patients With Locally Advanced or Recurrent Colorectal Cancer
NCT ID:
NCT06307548
Condition:
Locally Advanced Colorectal Carcinoma
Recurrent Colorectal Carcinoma
Stage III Colorectal Cancer
Conditions: Official terms:
Carcinoma
Colorectal Neoplasms
Recurrence
Aminolevulinic Acid
Levulinic acid
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Aminolevulinic Acid
Description:
Given PO
Arm group label:
Treatment (aminolevulinic, fluorescence-guided surgery, PDT)
Other name:
5-ALA
Other name:
5-Aminolaevulinic Acid
Other name:
5-Aminolevulinic Acid
Other name:
Amino-Levulinic Acid
Other name:
Delta Aminolevulinic Acid
Other name:
Delta-Aminolevulinic Acid
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood sample collection
Arm group label:
Treatment (aminolevulinic, fluorescence-guided surgery, PDT)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo CT
Arm group label:
Treatment (aminolevulinic, fluorescence-guided surgery, PDT)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized axial tomography (procedure)
Other name:
Computerized Tomography
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Procedure
Intervention name:
Fluorescence-Guided Surgery
Description:
Undergo fluorescence-guided surgery
Arm group label:
Treatment (aminolevulinic, fluorescence-guided surgery, PDT)
Other name:
Fluorescence-Guided Surgical Procedure
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging
Description:
Undergo MRI
Arm group label:
Treatment (aminolevulinic, fluorescence-guided surgery, PDT)
Other name:
Magnetic Resonance
Other name:
Magnetic resonance imaging (procedure)
Other name:
Magnetic Resonance Imaging Scan
Other name:
Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
Other name:
MR
Other name:
MR Imaging
Other name:
MRI
Other name:
MRI Scan
Other name:
MRIs
Other name:
NMR Imaging
Other name:
NMRI
Other name:
Nuclear Magnetic Resonance Imaging
Other name:
sMRI
Other name:
Structural MRI
Intervention type:
Drug
Intervention name:
Photodynamic Therapy
Description:
Undergo PDT
Arm group label:
Treatment (aminolevulinic, fluorescence-guided surgery, PDT)
Other name:
PDT
Other name:
Photoradiation Therapy
Intervention type:
Procedure
Intervention name:
Surgical Procedure
Description:
Undergo surgery
Arm group label:
Treatment (aminolevulinic, fluorescence-guided surgery, PDT)
Other name:
Operation
Other name:
Surgery
Other name:
Surgery Type
Other name:
Surgery, NOS
Other name:
Surgical
Other name:
Surgical Intervention
Other name:
Surgical Interventions
Other name:
Surgical Procedures
Other name:
Type of Surgery
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.
Detailed description:
PRIMARY OBJECTIVES:
- To test the accuracy of image-guided fluorescence to detect residual disease. (Phase
I)
- To determine the safety of intraoperative PDT after fluorescence-guided surgery in
patients with loco-regionally advanced or recurrent colorectal cancer undergoing
surgery. (Phase I)
- To determine the potential efficacy of intraoperative PDT (after image-guided
fluorescence surgery). (Phase II)
SECONDARY OBJECTIVES:
- To assess the relationship between disease free survival and changes in levels of
carcinoembryonic antigen (CEA) and circulating tumor DNA (ctDNA). (Phase II)
- To assess rate of recurrence by using standard-of-care computed tomography (CT)
and/or magnetic resonance imaging (MRI). (Phase II)
OUTLINE:
Patients receive aminolevulinic acid orally (PO) 2 to 4 hours prior to standard of care
(SOC) surgery. Patients then undergo image-guided fluorescence 5-10 minutes post surgery,
and intraoperative PDT 15-45 minutes post surgery. Patients also undergo computed
tomography (CT) or magnetic resonance imaging (MRI) during screening and on follow up.
Patients also undergo blood sample collection throughout the trial.
After completion of study treatment, patients are followed up at 3 months, 24 weeks, and
every 3 to 6 months for 3 years.
Criteria for eligibility:
Criteria:
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. Aspartate transaminase (AST)/alanine
transaminase (ALT) ≥ 2.5 x upper limit of normal [ULN]) will be excluded from the
study
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance
with study requirements
- Patients unwilling or unable to follow protocol requirements
- Any condition which in the investigator's opinion deems the participant an
unsuitable candidate to receive study drug and/or procedure
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Roswell Park Cancer Institute
Address:
City:
Buffalo
Zip:
14263
Country:
United States
Status:
Recruiting
Contact:
Last name:
Anthony S. Dakwar
Phone:
716-845-5807
Email:
Anthony.Dakwar@RoswellPark.org
Investigator:
Last name:
Anthony S. Dakwar
Email:
Principal Investigator
Start date:
July 30, 2024
Completion date:
June 1, 2027
Lead sponsor:
Agency:
Roswell Park Cancer Institute
Agency class:
Other
Collaborator:
Agency:
National Center for Advancing Translational Sciences (NCATS)
Agency class:
NIH
Source:
Roswell Park Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06307548
