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Colorectal Carcinoma Metastatic in the LiverPhase 1NCT03993327

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

A Phase 1 study testing Iodine I 124 Monoclonal Antibody M5A and Positron Emission Tomography in people with Colorectal Carcinoma Metastatic in the Liver and Metastatic Colorectal Carcinoma, run by City of Hope Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase I trial studies how well an imaging agent called I-124 M5A works in detecting CEA-positive colorectal cancer that has spread to the liver. I-124 M5A is a monoclonal antibody, called M5A, linked to a radioactive substance called I-124. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Iodine I 124 Monoclonal Antibody M5A and Positron Emission Tomography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteUnited States
Study dates
15 Jul 2020to 4 Jun 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • The effects of 124I-M5A on the developing fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation. Should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately
  • 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
  • The results of the imaging scans that are performed as part of the standard work up should be available and should have been done within 2 months prior to study entry
  • All subjects must have the ability to understand and the willingness to sign a written informed consent
  • Prior therapy (chemotherapy, immunotherapy, radiotherapy) must be completed at least 2 weeks prior to infusion of radiolabeled antibody

Who cannot join

  • Patients should not have any uncontrolled illness including ongoing or active infection
  • Patients who have allergy to iodine or iodine contrast agents are not eligible for this protocol
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to 124I-M5A
  • Patients must not have received prior chemotherapy or radiation for >= 2 weeks before study enrollment
  • Pregnant women are excluded from this study because 124I-M5A is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with 124I-M5A, breastfeeding should be discontinued if the mother is treated with 124I-M5A
  • Patients with single (= 1) liver metastasis are not eligible for this protocol
  • Any patient who has had exposure to mouse, chimeric (human/mouse) or humanized immunoglobulin and has antibody to the M5A
  • Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • City of Hope Medical Center

    Duarte, California, 91010

Other trials in United States

About this study

Official title: Pilot Study: Detection of Colorectal Metastatic Liver Disease Preoperatively Using 124I-Labeled M5A Monoclonal Antibody to Carcinoembryonic Antigen (CEA)

This phase I trial studies how well an imaging agent called I-124 M5A works in detecting CEA-positive colorectal cancer that has spread to the liver. I-124 M5A is a monoclonal antibody, called M5A, linked to a radioactive substance called I-124. M5A binds to CEA-positive cancer cells and may, through imaging scans, be able to detect liver metastases by picking up signals from I-124.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the ability of iodine I 124 monoclonal antibody M5A (124I-labeled M5A monoclonal antibody [MAb]) to localize to CEA positive gastrointestinal (GI) metastases primarily focused on the liver.

SECONDARY OBJECTIVES:

  1. To determine the safety and pharmacokinetics of administration of 124I-labeled M5A MAb.

II. To correlate the radiographic positron emission tomography (PET) images to the liver metastases pathology.

III. To assess if the I-124 imaging agent detected additional liver and additional extra-hepatic liver lesions not appreciated on standard imaging scans.

OUTLINE:

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

After completion of study, patients are followed up periodically for 1 year.

Being tested
Iodine I 124 Monoclonal Antibody M5A, Positron Emission Tomography
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Iodine I 124 Monoclonal Antibody M5ABiological

    Also called 124I-M5A, Iodine I 124 Anti-CEA Monoclonal Antibody M5A

    Given IV

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan

    Undergo PET scan

Study groups in NCT03993327
Study groupRoleWhat they receive
Diagnostic (iodine I 124 monoclonal antibody M5A, PET scan)ExperimentalPatients receive iodine I 124 monoclonal antibody M5A IV on day 0 and undergo PET scan on days 2 and 6.
Receives: Biological: Iodine I 124 Monoclonal Antibody M5A; Procedure: Positron Emission Tomography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tumor targeting pharmacokinetic parameters of iodine I 124 monoclonal antibody M5A

    Will be observed using standard imaging scans obtained pre-operatively and to assess if the antibody detects new liver metastases. Serum concentration data will be tabulated and descriptive statistics computed.

    Measured: Days 0, 2, and 6 drawn at approximately 1 hour, 2 hour and 3-4 hours post-end of infusion

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

    Measured: Up to 1 year

Secondary outcomes (5)

  1. Surgical results (when available per standard of care surgery/pathology) on lesions negative on I-124 M5A but positive on standard scans

    percent of patients with pathological confirmation of liver metastases

    Measured: Up to 1 year

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

    Measured: Up to 1 year

  3. Surgical pathology results (when available) on lesions positive on I-124 M5A but negative on standard imaging

    percent of patients with pathological confirmation of liver metastases

    Measured: Up to 1 year

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

    percent of patients with suspicious extra-hepatic lesions (both previously noted or new) identified on I-124 M5A but were not identified on standard imaging

    Measured: Up to 1 year

  5. Incidence of adverse events

    Will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Safety data will be displayed and abnormal laboratory values reported. The frequency of adverse events will be tabulated by body system.

    Measured: Up to 14 days post infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2019
  2. Study start15 Jul 2020
  3. Primary completion4 Jun 2024
  4. Study completion4 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03993327
Sponsor's protocol ID
18386
Other IDs
NCI-2019-01923, 18386
Status last verified
Jun 2024
First submitted
4 Jun 2019
Last updated
28 Jun 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Iodine I 124 Monoclonal Antibody M5A and Positron Emission Tomography in people with Colorectal Carcinoma Metastatic in the Liver and Metastatic Colorectal Carcinoma, run by City of Hope Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tumor targeting pharmacokinetic parameters of iodine I 124 monoclonal antibody M5A (time frame: Days 0, 2, and 6 drawn at approximately 1 hour, 2 hour and 3-4 hours post-end of infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03993327.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2024; AzTrials last refreshed its copy on 31 Oct 2026.

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