RecruitingEarly Phase 1NCT05245786

An Investigational Scan (64Cu-Labeled M5A Antibody) in Combination With SOC Chemotherapy and Radiotherapy in Locally Advanced Rectal Cancer

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)


Sponsor

City of Hope Medical Center

Enrollment

15 participants

Start Date

Aug 31, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a special type of imaging scan using a radioactive antibody (called 64Cu-M5A) in patients with locally advanced rectal cancer. The scan may help doctors better track how the cancer is responding to standard chemotherapy and radiation therapy before surgery. Researchers want to see how well this scan works alongside existing treatments. **You may be eligible if...** - You are 18 or older - You have confirmed locally advanced rectal cancer (T3 or T4 stage) - Your cancer produces a protein called CEA - You are scheduled to receive chemotherapy and radiation therapy before surgery - You are willing to use contraception during and for 6 months after the study **You may NOT be eligible if...** - You have uncontrolled illnesses - You are pregnant or breastfeeding - You are unable or unwilling to give informed consent - You have not completed prior chemotherapy or radiation at least 2 weeks before the scan Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALCopper Cu 64 Anti-CEA Monoclonal Antibody M5A

Given IV

PROCEDUREImaging Technique

Undergo imaging


Locations(1)

City of Hope Medical Center

Duarte, California, United States

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NCT05245786


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