Magnetic Particle-ICG Lymph Node Mapping in Colorectal Cancer
Primary Purpose
Colorectal Cancer
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
FerroTraceTM
indocyanine green (ICG)
Sponsored by
About this trial
This is an interventional diagnostic trial for Colorectal Cancer
Eligibility Criteria
Inclusion criteria:
- Age 18 or older
- Willing to provide informed consent
- Biopsy proven colon or rectal cancer
- No distant metastases
Exclusion criteria:
- Serious medical comorbidities or other contraindications to surgery +/- adjuvant therapy as determined by the treatment team
- Previous pelvic radiotherapy or radiotherapy planned prior to surgery
- Allergy or intolerance to iron oxide compounds
- Iron overload disorder
- Allergy or intolerance to iodides
- Pregnant or lactating women*
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
FerroTraceTM (magnetic tracer)
Arm Description
a special type of fluorescent dye called indocyanine green (ICG) during surgery can help surgeons find the lymph nodes that the cancer is most likely to have spread to in colorectal cancer patients.
Outcomes
Primary Outcome Measures
To assess the feasibility how the Sentinel Lymph Node (SLN) mapping by using novel magnetic tracers (FerroTrace) and using the indocyanine green (ICG) for colorectal cancer.
Secondary Outcome Measures
Full Information
NCT ID
NCT05092750
First Posted
September 21, 2021
Last Updated
September 25, 2023
Sponsor
M.D. Anderson Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT05092750
Brief Title
Magnetic Particle-ICG Lymph Node Mapping in Colorectal Cancer
Official Title
Magnetic Particle-ICG Lymph Node Mapping in Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Withdrawn
Why Stopped
0 accrual
Study Start Date
September 15, 2021 (Actual)
Primary Completion Date
August 29, 2023 (Actual)
Study Completion Date
August 29, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Study to determine the feasibility of Sentinel Lymph Node (SLN) mapping using novel magnetic tracers (FerroTrace) and indocyanine green (ICG) for colorectal cancer; and to evaluate safety by assessing short term toxicity associated with colonoscopic peritumoral injection of novel magnetic nanoparticles (FerroTrace) and ICG for colorectal cancer.
Detailed Description
PRIMARY:
To determine the feasibility of Sentinel Lymph Node (SLN) mapping using novel magnetic tracers (FerroTrace) and indocyanine green (ICG) for colorectal cancer.
To evaluate safety by assessing short term toxicity associated with colonoscopic peritumoral injection of novel magnetic nanoparticles (FerroTrace) and ICG for colorectal cancer.
SECONDARY:
1. To determine the additional positive diagnostic value of adding sentinel lymph node mapping to lymphadenectomy by assessing the SLNs with detailed immunochemistry versus the normal H&E staining pathology tests.
PRIMARY END POINTS:
Feasibility: Number of registered patients who complete all study procedures with at least one sentinel node identified.
Safety: Rate of any grade III or greater toxicity attributable to FerroTrace injection, evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0. Adverse events according to general peri-operative complications.
SECONDARY ENDPOINTS:
The identification rate and number of FerroTrace-positive lymph nodes for each patient.
Incidence of pathological upstaging of LN metastasis status by the addition of (non-routine) serial H&E and immunohistochemistry in the pathological assessment of identified FerroTrace-positive lymph nodes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FerroTraceTM (magnetic tracer)
Arm Type
Experimental
Arm Description
a special type of fluorescent dye called indocyanine green (ICG) during surgery can help surgeons find the lymph nodes that the cancer is most likely to have spread to in colorectal cancer patients.
Intervention Type
Device
Intervention Name(s)
FerroTraceTM
Intervention Description
A magnetic
Intervention Type
Drug
Intervention Name(s)
indocyanine green (ICG)
Intervention Description
Given by SC injection
Primary Outcome Measure Information:
Title
To assess the feasibility how the Sentinel Lymph Node (SLN) mapping by using novel magnetic tracers (FerroTrace) and using the indocyanine green (ICG) for colorectal cancer.
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Age 18 or older
Willing to provide informed consent
Biopsy proven colon or rectal cancer
No distant metastases
Exclusion criteria:
Serious medical comorbidities or other contraindications to surgery +/- adjuvant therapy as determined by the treatment team
Previous pelvic radiotherapy or radiotherapy planned prior to surgery
Allergy or intolerance to iron oxide compounds
Iron overload disorder
Allergy or intolerance to iodides
Pregnant or lactating women*
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Chang
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Links:
URL
http://www.mdanderson.org
Description
M D Anderson Cancer Center
Learn more about this trial
Magnetic Particle-ICG Lymph Node Mapping in Colorectal Cancer
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