Breast CancerNCT02293954
Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET in Diagnosing Patients With CEA Positive Cancer
A study testing radionuclide imaging, positron emission tomography and laboratory biomarker analysis in people with Breast Cancer and Colon Cancer, run by City of Hope Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Colon Cancer, Extrahepatic Bile Duct Cancer
- What is being tested?
- radionuclide imaging, positron emission tomography and laboratory biomarker analysis
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2015to 14 Jul 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically confirmed primary or metastatic cancer; if biopsies were performed at an outside facility, the histology must be reviewed and confirmed by the Department of Pathology at the City of Hope
- Patients must have tumors that produce CEA as documented by a current or past history of an elevated serum CEA above the institutional limit of normal, or by immunohistochemical methods; NOTE: Patients with colorectal cancer are exempt from this requirement since > 95% are CEA positive
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately
- Patients must have a known site of disease; please note, for patients undergoing neoadjuvant therapy, this requirement must be met retrospectively prior to the start of neoadjuvant therapy; patients who are in radiological/clinical remission after neoadjuvant therapy, prior to infusion of radiolabeled antibody, are still eligible
- Although not mandated by the protocol, the results of the CT scan and labs (complete blood count [CBC], comprehensive metabolic panel [CMP]) that are performed as part of the standard work up should be available and should have been done within 2 months prior to study entry
- All subjects must have the ability to understand and the willingness to sign a written informed consent
- Prior therapy (chemotherapy, immunotherapy, radiotherapy) must be completed at least 2 weeks prior to infusion of radiolabeled antibody
Who cannot join
- Patients should not have any uncontrolled illness including ongoing or active infection
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to copper Cu 64 anti-CEA monoclonal antibody M5A (64Cu-M5A)
- Patients must not have received prior chemotherapy or radiation for >= 2 weeks before study enrollment
- Pregnant women are excluded from this study; breastfeeding should be discontinued is the mother is treated with 54Cu-m5A
- Any patient who has had exposure to mouse or chimeric (human/mouse) immunoglobulin and has antibody to the M5A
- Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
Official title: Pilot Study: Detection of Carcinomas Using 64Cu-Labeled M5A Antibody to Carcinoembryonic Antigen (CEA)
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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
- Being tested
- radionuclide imaging, positron emission tomography, laboratory biomarker analysis, pharmacological study, Cu 64 anti-CEA monoclonal antibody M5A IV
- Medical subject headings
- Breast Neoplasms, Colonic Neoplasms, Bile Duct Neoplasms, Gallbladder Neoplasms, Gastrointestinal Neoplasms, Carcinoma, Hepatocellular, Lung Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radionuclide imagingProcedure or surgery
Also called radionuclide scanning
Given copper Cu 64 anti-CEA monoclonal antibody M5A IV
positron emission tomographyProcedure or surgery
Also called FDG-PET, PET, PET scan, tomography, emission computed
Undergo PET
laboratory biomarker analysisOther
Correlative studies
Also called pharmacological studies
Correlative studies
Cu 64 anti-CEA monoclonal antibody M5A IVDrug
Cu 64 anti-CEA monoclonal antibody M5A IV
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (copper Cu 64 anti-CEA monoclonal antibody M5A PET) | Experimental | Patients receive copper Cu 64 anti-CEA monoclonal antibody M5A IV on day 0 and then undergo PET on day 1 and day 2. Receives: Procedure: radionuclide imaging; Procedure: positron emission tomography; Other: laboratory biomarker analysis; Other: pharmacological study; Drug: Cu 64 anti-CEA monoclonal antibody M5A IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor Uptake of 64Cu-DOTA-hT4.66-M5A at Day 1
Tumor uptake measured by SUVmax of 64Cu-DOTA-hT4.66-M5A at day1 for hottest lesion from each patient. For tumors of at least 2 cm in diameter SUV (=tumor activity concentration/injected activity per unit body weight).
Measured: At day 1
Tumor Uptake of 64Cu-DOTA-hT4.66-M5A at Day 2
Tumor uptake measured by SUVmax of 64Cu-DOTA-hT4.66-M5A at day 2 for hottest lesion from each patient. For tumors of at least 2 cm in diameter SUV (=tumor activity concentration/injected activity per unit body weight).
Measured: At day 2
Secondary outcomes (2)
Number of Participants With Human Anti-human Antibody (HAHA) Positive Response to 64Cu Labeled M5A Antibody
Approximately 5 ml (1 teaspoon) of blood in a red top tube will be drawn at 1 month post study drug infusion and 3 months post study drug infusion. Response at either 1 or 3 months post study drug infusion constitutes a positive response.
Measured: At 1 and 3 months post study drug infusion
The Average Increase of Tumor-to-blood (T:B) Ratio From Day 1 to Day 2
Scan results were compared to known sites of disease as defined by sites identified on CT scans, MRI scans, FDG PET scans, or sites identified at surgery that were histologically positive for cancer. The 64Cu SUVs on both day 1 and 2 scans were evaluated in tumors and selected nontumor organs and tissues (blood pool, liver, spleen, and kidney). Tumor uptake was measured in terms of SUVmax values, while organ uptake to assess biodistribution was measured in terms of SUVmean values. Ratios of tumor-to-blood activity concentration (T:B) were calculated as the ratio of tumor SUVmax to average SUV (SUVmean) measured in the blood pool.
Measured: At day 1 and day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2014 (estimated)
- Study start11 Nov 2015
- Primary completion6 Mar 2022
- Study completion14 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Wong, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02293954
- Sponsor's protocol ID
- 14238
- Other IDs
- NCI-2014-02079, 14238
- Status last verified
- Aug 2026
- First submitted
- 9 Oct 2014
- Last updated
- 24 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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. 2023 Feb;38(1):26-37. doi: 10.1089/cbr.2022.0028. Epub 2022 Sep 26.
PubMed 36154291