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Investigational Scan + Chemotherapy/Radiotherapy for Rectal Cancer

Q: How many participants are actively contributing to this research?

<p>Affirmative, the information on clinicaltrials.gov verifies that this research trial is actively enrolling prospective participants. The initial posting was released August 31st 2022 and it was recently updated October 26th of the same year. There are 15 spots available at a single medical centre.</p>

Q: Is this research effort currently enrolling participants?

<p>A glance at the details shared on clinicaltrials.gov reveals that this research is proactively recruiting participants. The study was initially posted in August of 2022 and has been updated as recently as October 26th, 2022.</p>

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Positron-Emission Tomography

Secondary outcome measures

Count of Adverse Events.

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 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor

565 Previous Clinical Trials

1,921,445 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,660 Previous Clinical Trials

40,924,666 Total Patients Enrolled

Jeffrey Y WongPrincipal InvestigatorCity of Hope Medical Center

8 Previous Clinical Trials

210 Total Patients Enrolled

Media Library

Copper Cu 64 Anti-CEA Monoclonal Antibody M5A Clinical Trial Eligibility Overview. Trial Name: NCT05245786 — Phase < 1

Rectal Cancer Research Study Groups: Treatment (64Cu labeled M5A antibody and imaging)

Rectal Cancer Clinical Trial 2023: Copper Cu 64 Anti-CEA Monoclonal Antibody M5A Highlights & Side Effects. Trial Name: NCT05245786 — Phase < 1

Copper Cu 64 Anti-CEA Monoclonal Antibody M5A 2023 Treatment Timeline for Medical Study. Trial Name: NCT05245786 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are actively contributing to this research?

"Affirmative, the information on clinicaltrials.gov verifies that this research trial is actively enrolling prospective participants. The initial posting was released August 31st 2022 and it was recently updated October 26th of the same year. There are 15 spots available at a single medical centre."

Answered by AI

Is this research effort currently enrolling participants?

"A glance at the details shared on clinicaltrials.gov reveals that this research is proactively recruiting participants. The study was initially posted in August of 2022 and has been updated as recently as October 26th, 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "An Investigational Scan (64Cu-Labeled M5A Antibody) in Combination With SOC Chemotherapy and Radiotherapy in Locally Advanced Rectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05245786.