Clinical trialNAActive not recruiting
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)
- Outcome
- Ongoing
- Phase
- NA
- Status
- Active not recruiting
- Study type
- Interventional
- Start
- 11 November 2015
- Expected end
- 14 July 2027
- Enrollment
- 20 participants
- Sites
- 1
- Primary outcomes
- Tumor Uptake of 64Cu-DOTA-hT4.66-M5A at Day 1; Tumor Uptake of 64Cu-DOTA-hT4.66-M5A at Day 2
- Sponsor
- Other
- Results posted
- 2023-04-21
- Last update
- 24 September 2026
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Brief summary public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
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.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Tumor Uptake of 64Cu-DOTA-hT4.66-M5A at Day 1 [At day 1]. Median, SUVmax (g/mL) (Standard Deviation). Diagnostic (Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET) (n=20): 22.0 (16.9).
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Tumor Uptake of 64Cu-DOTA-hT4.66-M5A at Day 2 [At day 2]. Mean, SUVmax (g/mL) (Standard Deviation). Diagnostic (Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET) (n=20): 30.7 (24.4).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Participants With Human Anti-human Antibody (HAHA) Positive Response to 64Cu Labeled M5A Antibody [At 1 and 3 months post study drug infusion]. Count Of Participants, Participants. Diagnostic (Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET) (n=20): 1.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
The Average Increase of Tumor-to-blood (T:B) Ratio From Day 1 to Day 2 [At day 1 and day 2]. Mean, T:B (Standard Deviation). Day 1: Diagnostic (Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET) (n=20): 3.3 (2.7). Day 2: Diagnostic (Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET) (n=20): 6.5 (4.9).