Investigating a new imaging method for advanced rectal cancer treatment
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)
This study is testing a new imaging method using a special antibody scan to see if it can help doctors better understand how well treatment is working for people with advanced rectal cancer.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | City of Hope Medical Center Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Duarte, California) |
| Trial ID | NCT05245786 on ClinicalTrials.gov |
What this trial studies
This early phase I trial evaluates the effectiveness of a 64Cu-labeled M5A antibody scan in assessing tumor activity in patients with locally advanced rectal cancer undergoing standard chemotherapy and radiotherapy. The study aims to determine if this imaging technique can influence treatment decisions before and after therapy. Patients will receive the antibody intravenously and undergo PET scans to monitor tumor response. The trial will also assess the safety of the antibody and summarize imaging findings in relation to standard scans and pathology.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed CEA-expressing locally advanced rectal cancer scheduled for neoadjuvant chemotherapy and radiation therapy.
Not a fit: Patients with non-CEA expressing tumors or those not scheduled for neoadjuvant therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance treatment planning and improve outcomes for patients with locally advanced rectal cancer.
How similar studies have performed: While this specific approach is novel, similar imaging techniques have shown promise in other cancer types, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 should inform her treating physician immediately * Patients must have a known site of disease. Patients must be scheduled to undergo neoadjuvant chemotherapy and radiation therapy followed by surgery * Patients who are planned for total neoadjuvant therapy where additional chemotherapy is planned before neoadjuvant chemoradiotherapy (CRT) are also eligible * Although not mandated by the protocol, the results of the computed tomography (CT), magnetic resonance imaging (MRI) and fludeoxyglucose F-18 (FDG) PET scans and labs (blood cell 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 * Patients may not be receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy * History of allergic reactions attributed to compounds of similar chemical or biologic composition to 64Cu-M5A * Pregnant women are excluded from this study because 64Cu-M5A is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with \^64Cu-M5A, breastfeeding should be discontinued if the mother is treated with 64Cu-M5A * Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
Where this trial is running
Duarte, California
- City of Hope Medical Center — Duarte, California, United States (Recruiting)
Study contacts
- Principal investigator: Jeffrey Y Wong — City of Hope Medical Center
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.