I-124 M5A Imaging for Metastatic Colorectal Cancer

Overseen by Savita V Dandapani

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: City of Hope Medical Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial studies how well an imaging agent called I-124 M5A works in detecting colorectal cancer that has spread to the liver. The agent combines an antibody that finds cancer cells with a radioactive signal that makes them visible on scans. It targets patients with a specific type of cancer that may not be easily detected with standard imaging techniques. The M5A antibody has been extensively studied for its effectiveness in targeting colorectal cancer.

Research Team

Savita V Dandapani

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

This trial is for adults with colorectal cancer that has spread to the liver. They must have at least two known liver metastases, one of which can be surgically removed. Participants need recent imaging scans and should not have had any cancer treatments in the last two weeks. Women who can bear children and men must use contraception, and pregnant women are excluded.

Inclusion Criteria

I finished any cancer treatments like chemotherapy or radiotherapy at least 2 weeks ago.

Results of imaging scans should be available and done within 2 months prior to study entry

Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for six months following duration of study participation. Pregnant women should inform their treating physician immediately

Exclusion Criteria

You are allergic to iodine or substances that contain iodine.

I am not pregnant and will stop breastfeeding if treated.

I do not have only one liver metastasis.

Treatment Details

Interventions

• Iodine I 124 Monoclonal Antibody M5A (Monoclonal Antibodies)

Trial Overview The trial tests I-124 M5A, a radioactive antibody that binds to cancer cells in the liver, using PET scans for detection. It aims to see how well this agent shows up on scans to locate tumors in patients whose colorectal cancer has spread to their livers.

Participant Groups

Group I: Diagnostic (iodine I 124 monoclonal antibody M5A, PET scan) Experimental Treatment 2 Interventions

Patients receive iodine I 124 monoclonal antibody M5A IV on day 0 and undergo PET scan on days 2 and 6.

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+