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An Imaging Agent (I-124 M5A) in Detecting CEA-Positive Liver Metastases in Patients With Colorectal Cancer

Stage IV Colorectal Cancer AJCC v8 Clinical Trial

Official title:
Pilot Study: Detection of Colorectal Metastatic Liver Disease Preoperatively Using 124I-Labeled M5A Monoclonal Antibody to Carcinoembryonic Antigen (CEA)

Clinical Trial Summary

This phase I trial studies how well an imaging agent called I-124 M5A works in detecting CEA-positive colorectal cancer that has spread to the liver. I-124 M5A is a monoclonal antibody, called M5A, linked to a radioactive substance called I-124. M5A binds to CEA-positive cancer cells and may, through imaging scans, be able to detect liver metastases by picking up signals from I-124.

Clinical Trial Description

PRIMARY OBJECTIVES: I. To determine the ability of iodine I 124 monoclonal antibody M5A (124I-labeled M5A monoclonal antibody [MAb]) to localize to CEA positive gastrointestinal (GI) metastases primarily focused on the liver. SECONDARY OBJECTIVES: I. To determine the safety and pharmacokinetics of administration of 124I-labeled M5A MAb. II. To correlate the radiographic positron emission tomography (PET) images to the liver metastases pathology. III. To assess if the I-124 imaging agent detected additional liver and additional extra-hepatic liver lesions not appreciated on standard imaging scans. OUTLINE: Patients receive iodine I 124 monoclonal antibody M5A intravenously (IV) on day 0 and undergo PET scan on days 2 and 6. After completion of study, patients are followed up periodically for 1 year. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03993327
Study type Interventional
Source City of Hope Medical Center
Contact
Status Active, not recruiting
Phase Phase 1
Start date July 15, 2020
Completion date June 8, 2024
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