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Investigational Scan + Chemotherapy/Radiotherapy for Rectal Cancer

Phase < 1

Recruiting

Led By Jeffrey Y Wong

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have a known site of disease and be scheduled to undergo neoadjuvant chemotherapy and radiation therapy followed by surgery

Patients must be 18 years of age or older

Must not have

Breastfeeding should be discontinued if the mother is treated with 64Cu-M5A

Patients should not have any uncontrolled illness including ongoing or active infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing how well a 64Cu-labeled M5A antibody scan works in assessing tumor activity before and after chemotherapy and radiotherapy in patients with locally advanced rectal cancer.

Who is the study for?

This trial is for adults with advanced rectal cancer that can be detected on scans and who are scheduled for chemotherapy, radiation, then surgery. They must have completed any previous treatments at least two weeks before the study starts and agree to use contraception. Pregnant women, those with allergies to similar drugs, uncontrolled illnesses or infections, or taking other experimental treatments cannot participate.

What is being tested?

The trial is testing a new imaging technique using a scan called 64Cu-labeled M5A antibody PET/CT to see how well it shows tumor activity in patients undergoing standard chemo and radiotherapy for locally advanced rectal cancer.

What are the potential side effects?

Potential side effects may include allergic reactions related to the chemical composition of the 64Cu-M5A compound used in the investigational scan. Specific side effects are not detailed but would likely relate to this type of diagnostic agent.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for chemo, radiation, and surgery for my cancer.

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I am 18 years old or older.

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My rectal cancer is advanced but hasn't spread far and tests positive for CEA.

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I finished my last cancer treatment at least 2 weeks ago.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I will stop breastfeeding if treated with 64Cu-M5A.

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I do not have any uncontrolled illnesses or active infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Positron-Emission Tomography

Secondary study objectives

Count of Adverse Events.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (64Cu labeled M5A antibody and imaging)Experimental Treatment2 Interventions

Patients receive 64Cu labeled M5A antibody IV over 5 minutes on day 0 pre standard of care chemo/radiotherapy and on day 0 post chemo/radiotherapy. Patients also undergo 64Cu-M5A PET scan on day 1 pre chemo/radiotherapy and on day 1 post chemo/radiotherapy.

0 / 6Eligibility criteria met