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Clinical Trial Details — Status: Withdrawn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
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• 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
• 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• Status: Withdrawn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*

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

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

External Links

•   M D Anderson Cancer Center