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NCT05092750 Clinical Trial

Magnetic Particle-ICG Lymph Node Mapping in Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:
Magnetic Particle-ICG Lymph Node Mapping in Colorectal Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT05092750
Other study ID # 2021-0479
Secondary ID
Status Withdrawn
Phase Phase 1/Phase 2
First received
Last updated
Start date September 15, 2021
Est. completion date August 29, 2023

Study information
Verified date September 2023
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

PRIMARY: 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date August 29, 2023
Est. primary completion date August 29, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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*

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• FerroTraceTM
A magnetic
Drug:
• indocyanine green (ICG)
Given by SC injection

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
M.D. Anderson Cancer Center

Outcome
Type Measure Description Time frame Safety issue
Primary 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. through study completion, an average of 1 year
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