Pilot Study: Imaging Tumor Extent and Response Before and After Neoadjuvant Chemotherapy and Radiotherapy in Locally Advanced Rectal Cancer Using 64Cu-Labeled M5A Antibody to Carcinoembryonic Antigen (CEA)
City of Hope Medical Center
Summary
This early phase I trial investigates how well 64Cu-labeled M5A antibody scan works in assessing tumor activity before and after patients with rectal cancer that has spread to nearby tissue or lymph nodes (locally advanced) who are undergoing chemotherapy and radiotherapy. Using 64Cu-labeled M5A positron emission tomography imaging may play a significant role in imaging patients with colorectal cancer.
Description
PRIMARY OBJECTIVE: I. To determine if the Copper Cu 64 anti-carcinoembryonic antigen (CEA) monoclonal antibody M5A (64Cu labeled M5A antibody) demonstrates a potentially impactful finding for patient management either in the pre-treatment scan (potentially impacting choice of therapy or impacting the radiotherapy \[RT\] plan) or the scan immediately prior to planned surgery (after standard care \[SOC\] chemoradiation) in patients with locally advanced rectal cancer. SECONDARY OBJECTIVES: I. To determine the safety of administration of 64Cu labeled M5A antibody. II. To describe/summarize eac…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients must have histologically confirmed CEA expressing locally advanced rectal cancer (T3, T4 and N0 or N plus \[+\]) * Patients must be 18 years of age or older * The effects of 64Cu-M5A on the developing fetus are unknown. For this reason, 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 shoul…
Interventions
- BiologicalCopper Cu 64 Anti-CEA Monoclonal Antibody M5A
Given IV
- ProcedureImaging Technique
Undergo imaging
Location
- City of Hope Medical CenterDuarte, California