Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET in Diagnosing Patients With CEA Positive Cancer
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ClinicalTrials.gov Identifier: NCT02293954 |
Recruitment Status :
Active, not recruiting
First Posted : November 19, 2014
Last Update Posted : October 21, 2022
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Tracking Information | ||||
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First Submitted Date ICMJE | October 9, 2014 | |||
First Posted Date ICMJE | November 19, 2014 | |||
Last Update Posted Date | October 21, 2022 | |||
Actual Study Start Date ICMJE | November 11, 2015 | |||
Estimated Primary Completion Date | September 11, 2023 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
Incidence of adverse events graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 [ Time Frame: Up to 3 months ] Safety data will be displayed and abnormal laboratory values flagged. The frequency of adverse events will be tabulated by body system.
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET in Diagnosing Patients With CEA Positive Cancer | |||
Official Title ICMJE | Pilot Study: Detection of Carcinomas Using 64Cu-Labeled M5A Antibody to Carcinoembryonic Antigen (CEA) | |||
Brief 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. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE | Experimental: Diagnostic (copper Cu 64 anti-CEA monoclonal antibody M5A PET)
Patients receive copper Cu 64 anti-CEA monoclonal antibody M5A IV on day 0 and then undergo PET on day 1 and day 2.
Interventions:
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Publications * | Wong JYC, Yamauchi DM, Adhikarla V, Simpson J, Frankel PH, Fong Y, Melstrom KA, Chen YJ, Salehian BD, Woo Y, Dandapani SV, Colcher DM, Poku EK, Yazaki PJ, Wu AM, Shively JE. First-In-Human Pilot PET Immunoimaging Study of 64Cu-Anti-Carcinoembryonic Antigen Monoclonal Antibody (hT84.66-M5A) in Patients with Carcinoembryonic Antigen-Producing Cancers. Cancer Biother Radiopharm. 2022 Sep 26. doi: 10.1089/cbr.2022.0028. Online ahead of print. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Active, not recruiting | |||
Actual Enrollment ICMJE |
20 | |||
Original Estimated Enrollment ICMJE |
10 | |||
Estimated Study Completion Date ICMJE | September 11, 2023 | |||
Estimated Primary Completion Date | September 11, 2023 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02293954 | |||
Other Study ID Numbers ICMJE | 14238 NCI-2014-02079 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 14238 ( Other Identifier: City of Hope Medical Center ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | City of Hope Medical Center | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | City of Hope Medical Center | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | National Cancer Institute (NCI) | |||
Investigators ICMJE |
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PRS Account | City of Hope Medical Center | |||
Verification Date | October 2022 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |