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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
Must not have
Pregnant women are excluded from this study. Breastfeeding should be discontinued if the mother is treated with 124I-M5A
Patients with single (= 1) liver metastasis are not eligible for this protocol
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
No Placebo-Only Group
Summary
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.
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.
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.
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 belowSelect...
I have at least two liver tumors, and one can be surgically removed.
Select...
My colorectal cancer has spread to my liver.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not pregnant and will stop breastfeeding if treated.
Select...
I do not have only one liver metastasis.
Select...
I do not have any uncontrolled illnesses or active infections.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Tumor targeting pharmacokinetic parameters of iodine I 124 monoclonal antibody M5A
Secondary study objectives
I-124 identification of extra-hepatic lesions (both previously noted or new)
Incidence of adverse events
Surgical pathology results (when available) on lesions positive on I-124 M5A but negative on standard imaging
+1 moreAwards & 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: 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
2011
Completed Phase 2
~2200
Iodine I 124 Monoclonal Antibody M5A
2020
Completed Phase 1
~10
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Monoclonal antibodies, such as I-124 M5A, target specific antigens like carcinoembryonic antigen (CEA) on colorectal cancer cells and can be linked to radioactive substances for precise imaging or treatment. This targeted approach allows for accurate detection and destruction of cancer cells while sparing healthy tissue.
Other common treatments include chemotherapy, which kills rapidly dividing cells, and immunotherapy, which enhances the immune system's ability to fight cancer. These therapies are vital for colorectal cancer patients as they provide targeted, effective options to manage and potentially eliminate the disease.
Phase I/II trial of combined 131I anti-CEA monoclonal antibody and hyperthermia in patients with advanced colorectal adenocarcinoma.CEA Response and Depth of Response (DpR) to Predict Clinical Outcomes of First-Line Cetuximab Treatment for Metastatic Colorectal Cancer.[Drug therapy of colorectal carcinoma].
Phase I/II trial of combined 131I anti-CEA monoclonal antibody and hyperthermia in patients with advanced colorectal adenocarcinoma.CEA Response and Depth of Response (DpR) to Predict Clinical Outcomes of First-Line Cetuximab Treatment for Metastatic Colorectal Cancer.[Drug therapy of colorectal carcinoma].
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
598 Previous Clinical Trials
1,923,372 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,886 Previous Clinical Trials
41,020,955 Total Patients Enrolled
Savita V DandapaniPrincipal InvestigatorCity of Hope Medical Center
3 Previous Clinical Trials
39 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I finished any cancer treatments like chemotherapy or radiotherapy at least 2 weeks ago.I haven't had chemotherapy or radiation in the last 2 weeks.I do not have any uncontrolled illnesses or active infections.I have at least two liver tumors, and one can be surgically removed.My colorectal cancer has spread to my liver.
Research Study Groups:
This trial has the following groups:- Group 1: Diagnostic (iodine I 124 monoclonal antibody M5A, PET scan)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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