Trials / Completed
CompletedNCT03993327
An Imaging Agent (I-124 M5A) in Detecting CEA-Positive Liver Metastases in Patients With Colorectal Cancer
Pilot Study: Detection of Colorectal Metastatic Liver Disease Preoperatively Using 124I-Labeled M5A Monoclonal Antibody to Carcinoembryonic Antigen (CEA)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 4 (actual)
- Sponsor
- City of Hope Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
- Colorectal Carcinoma Metastatic in the Liver
- Metastatic Colorectal Carcinoma
- Stage IV Colorectal Cancer AJCC v8
- Stage IVA Colorectal Cancer AJCC v8
- Stage IVB Colorectal Cancer AJCC v8
- Stage IVC Colorectal Cancer AJCC v8
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Iodine I 124 Monoclonal Antibody M5A | Given IV |
| PROCEDURE | Positron Emission Tomography | Undergo PET scan |
Timeline
- Start date
- 2020-07-15
- Primary completion
- 2024-06-04
- Completion
- 2024-06-04
- First posted
- 2019-06-20
- Last updated
- 2024-06-28
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03993327. Inclusion in this directory is not an endorsement.