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I-124 M5A Imaging for Metastatic Colorectal Cancer

Phase 1

Waitlist Available

Led By Savita V Dandapani

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 at least 2 known sites of metastatic liver disease. Patients should have at least one resectable liver metastasis as assessed by hepatobiliary surgical oncology

Patients must have histologically confirmed metastatic colorectal cancer with liver metastases. NOTE: We are not requiring proof of CEA positive disease because > 95% of colorectal cancers are CEA positive

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

Study Summary

This trial is studying how well an imaging agent called I-124 M5A can detect colorectal cancer that has spread to the liver.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects may include allergic reactions related to the monoclonal antibody or iodine content of I-124 M5A, as well as general risks associated with exposure to radioactivity such as nausea or radiation sickness.

Eligibility Criteria

Inclusion Criteria

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

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I have at least two liver tumors, and one can be surgically removed.

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My colorectal cancer has spread to my liver.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Percent of known liver lesions per standard staging scans identified on iodine I-124 (I-124) M5A imaging

Tumor targeting pharmacokinetic parameters of iodine I 124 monoclonal antibody M5A

Secondary outcome measures

I-124 identification of extra-hepatic lesions (both previously noted or new)

Incidence of adverse events

Percent of patients with suspicious liver lesions identified on I-124 M5A but were not identified on standard imaging

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diagnostic (iodine I 124 monoclonal antibody M5A, PET scan)Experimental Treatment2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Positron Emission Tomography

2008

Completed Phase 2

~2240

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor

565 Previous Clinical Trials

1,921,456 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,663 Total Patients Enrolled

Savita V DandapaniPrincipal InvestigatorCity of Hope Medical Center

3 Previous Clinical Trials

39 Total Patients Enrolled

Media Library

Iodine I 124 Monoclonal Antibody M5A Clinical Trial Eligibility Overview. Trial Name: NCT03993327 — Phase 1

Colorectal Cancer Research Study Groups: Diagnostic (iodine I 124 monoclonal antibody M5A, PET scan)

Colorectal Cancer Clinical Trial 2023: Iodine I 124 Monoclonal Antibody M5A Highlights & Side Effects. Trial Name: NCT03993327 — Phase 1

Iodine I 124 Monoclonal Antibody M5A 2023 Treatment Timeline for Medical Study. Trial Name: NCT03993327 — Phase 1

Frequently Asked Questions

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

What diseases does Iodine-124 Monoclonal Antibody M5A offer relief for?

"Iodine I 124 Monoclonal Antibody M5A is a viable option for treating communicable diseases, as well as providing antisepsis and prophylaxis against infections in minor cuts or burns."

Answered by AI

Has the Iodine I 124 Monoclonal Antibody M5A gained approval from the FDA?

"As Iodine I 124 Monoclonal Antibody M5A is currently in phase 1, the safety of this medication was evaluated as a score 1 due to its limited data regarding efficacy and security."

Answered by AI

Are prospective participants still able to join this research project?

"Unfortunately, this medical research is not currently recruiting new participants. Initially posted on July 15th 2020 and most recently altered on June 7th 2022, it may be worth exploring other trials related to metastatic colorectal carcinoma (3237 studies) or Iodine I 124 Monoclonal Antibody M5A (15 studies)."

Answered by AI

Is there any precedent for the use of Iodine I 124 Monoclonal Antibody M5A in clinical trials?

"Currently, 15 clinical trials for Iodine I 124 Monoclonal Antibody M5A are ongoing with two in their late stages of development. Across 37 different medical centres, primarily based in Sevilla and Vizcaya, these studies are taking place."

Answered by AI

What is the scope of participation in this experiment?

"Unfortunately, this clinical trial is presently not accepting new patients. The investigation was first posted on July 15th 2020 and last amended on June 7th 2022. However, there are other medical studies involving metastatic colorectal carcinoma that have 3237 open positions as well as fifteen trials for Iodine I 124 Monoclonal Antibody M5A still recruiting participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

An Imaging Agent (I-124 M5A) in Detecting CEA-Positive Liver Metastases in Patients With Colorectal Cancer

2020. "An Imaging Agent (I-124 M5A) in Detecting CEA-Positive Liver Metastases in Patients With Colorectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03993327.

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