Ignite Creation Date:
2025-12-24 @ 4:59 PM
Ignite Modification Date:
2025-12-27 @ 4:49 AM
Study NCT ID:
NCT05092750
Status:
WITHDRAWN
Last Update Posted:
2023-09-28
First Post:
2021-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Magnetic Particle-ICG Lymph Node Mapping in Colorectal Cancer
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Magnetic Particle-ICG Lymph Node Mapping in Colorectal Cancer
Status:
WITHDRAWN
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
0 accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: