Active Not RecruitingNot applicableNCT02293954

Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET in Diagnosing Patients With CEA Positive Cancer

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.

Checked against the public recordLast updated Nov 14, 2025 · Source: ClinicalTrials.gov

StatusActive Not Recruiting
PhaseNot applicable
U.S. locations1
SponsorCity of Hope Medical Center
01
Study overview

What this study is about

Purpose
Diagnostic
Study type
Interventional
Phase
Not applicable
Sponsor
City of Hope Medical Center
Interventions being studied
Procedure: radionuclide imaging; Procedure: positron emission tomography; Other: laboratory biomarker analysis; Other: pharmacological study; Drug: Cu 64 anti-CEA monoclonal antibody M5A IV
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • City of Hope Medical CenterDuarte, California

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 14, 2025. Always confirm current availability with the study team.

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