Magnetic Particle-ICG Lymph Node Mapping in Colorectal Cancer
NCT ID: NCT05092750
Last Updated: 2023-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1/PHASE2
INTERVENTIONAL
2021-09-15
2023-08-29
Brief Summary
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Detailed Description
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1. To determine the feasibility of Sentinel Lymph Node (SLN) mapping using novel magnetic tracers (FerroTrace) and indocyanine green (ICG) for colorectal cancer.
2. 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:
1. Feasibility: Number of registered patients who complete all study procedures with at least one sentinel node identified.
2. 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:
1. The identification rate and number of FerroTrace-positive lymph nodes for each patient.
2. 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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FerroTraceTM (magnetic tracer)
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.
FerroTraceTM
A magnetic
indocyanine green (ICG)
Given by SC injection
Interventions
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FerroTraceTM
A magnetic
indocyanine green (ICG)
Given by SC injection
Eligibility Criteria
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Inclusion Criteria
* Willing to provide informed consent
* Biopsy proven colon or rectal cancer
* No distant metastases
Exclusion Criteria
* 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\*
18 Years
ALL
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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George Chang
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Related Links
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M D Anderson Cancer Center
Other Identifiers
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2021-0479
Identifier Type: -
Identifier Source: org_study_id
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