Trials / Active Not Recruiting
Active Not RecruitingNCT02293954
Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET in Diagnosing Patients With CEA Positive Cancer
Pilot Study: Detection of Carcinomas Using 64Cu-Labeled M5A Antibody to Carcinoembryonic Antigen (CEA)
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- City of Hope Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This pilot clinical trial studies copper Cu 64 anti-carcinoembryonic antigen (CEA) monoclonal antibody M5A positron emission tomography (PET) in diagnosing patients with CEA positive cancer. Diagnostic procedures, such as copper Cu 64 anti-CEA monoclonal antibody M5A PET, may help find and diagnose CEA positive cancer that may not be detected by standard diagnostic methods.
Detailed description
PRIMARY OBJECTIVES: I. To determine the ability of 64Cu labeled M5A antibody (copper Cu 64 anti-CEA monoclonal antibody M5A) to localize CEA positive cancers (such as gastrointestinal, lung, medullary thyroid and breast cancers), as determined by PET imaging. SECONDARY OBJECTIVES: I. To characterize the frequency of titer of the human anti-human antibody (HAHA) response to 64Cu labeled M5A antibody. II. To determine the safety of administration of 64Cu labeled M5A antibody. OUTLINE: Patients receive copper Cu 64 anti-CEA monoclonal antibody M5A intravenously (IV) on day 0 and then undergo PET on day 1 and day 2. After completion of study, patients are followed up at 1 and 3 months.
Conditions
- Breast Cancer
- Colon Cancer
- Extrahepatic Bile Duct Cancer
- Gallbladder Cancer
- Gastrointestinal Cancer
- Liver and Intrahepatic Biliary Tract Cancer
- Lung Cancer
- Metastatic Cancer
- Pancreatic Cancer
- Rectal Cancer
- Thyroid Gland Medullary Carcinoma
- Unspecified Adult Solid Tumor, Protocol Specific
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | radionuclide imaging | Given copper Cu 64 anti-CEA monoclonal antibody M5A IV |
| PROCEDURE | positron emission tomography | Undergo PET |
| OTHER | laboratory biomarker analysis | Correlative studies |
| OTHER | pharmacological study | Correlative studies |
| DRUG | Cu 64 anti-CEA monoclonal antibody M5A IV | Cu 64 anti-CEA monoclonal antibody M5A IV |
Timeline
- Start date
- 2015-11-11
- Primary completion
- 2022-03-06
- Completion
- 2026-08-11
- First posted
- 2014-11-19
- Last updated
- 2025-11-14
- Results posted
- 2023-04-21
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02293954. Inclusion in this directory is not an endorsement.