search
Back to results

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

Primary Purpose

Colorectal Carcinoma Metastatic in the Liver, Metastatic Colorectal Carcinoma, Stage IV Colorectal Cancer AJCC v8

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Iodine I 124 Monoclonal Antibody M5A
Positron Emission Tomography
Sponsored by
City of Hope Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colorectal Carcinoma Metastatic in the Liver

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • City of Hope Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (iodine I 124 monoclonal antibody M5A, PET scan)

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 4, 2019
Last Updated
June 12, 2023
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT03993327
Brief Title
An Imaging Agent (I-124 M5A) in Detecting CEA-Positive Liver Metastases in Patients With Colorectal Cancer
Official Title
Pilot Study: Detection of Colorectal Metastatic Liver Disease Preoperatively Using 124I-Labeled M5A Monoclonal Antibody to Carcinoembryonic Antigen (CEA)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 15, 2020 (Actual)
Primary Completion Date
December 8, 2023 (Anticipated)
Study Completion Date
December 8, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.
Detailed Description
PRIMARY OBJECTIVES: I. 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: I. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Carcinoma Metastatic in the Liver, Metastatic Colorectal Carcinoma, Stage IV Colorectal Cancer AJCC v8, Stage IVA Colorectal Cancer AJCC v8, Stage IVB Colorectal Cancer AJCC v8, Stage IVC Colorectal Cancer AJCC v8

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (iodine I 124 monoclonal antibody M5A, PET scan)
Arm Type
Experimental
Arm Description
Patients receive iodine I 124 monoclonal antibody M5A IV on day 0 and undergo PET scan on days 2 and 6.
Intervention Type
Biological
Intervention Name(s)
Iodine I 124 Monoclonal Antibody M5A
Other Intervention Name(s)
124I-M5A, Iodine I 124 Anti-CEA Monoclonal Antibody M5A
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
Positron Emission Tomography
Other Intervention Name(s)
Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging
Intervention Description
Undergo PET scan
Primary Outcome Measure Information:
Title
Tumor targeting pharmacokinetic parameters of iodine I 124 monoclonal antibody M5A
Description
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.
Time Frame
Days 0, 2, and 6 drawn at approximately 1 hour, 2 hour and 3-4 hours post-end of infusion
Title
Percent of known liver lesions per standard staging scans identified on iodine I-124 (I-124) M5A imaging
Time Frame
Up to 1 year
Secondary Outcome Measure Information:
Title
Surgical results (when available per standard of care surgery/pathology) on lesions negative on I-124 M5A but positive on standard scans
Description
percent of patients with pathological confirmation of liver metastases
Time Frame
Up to 1 year
Title
Percent of patients with suspicious liver lesions identified on I-124 M5A but were not identified on standard imaging
Time Frame
Up to 1 year
Title
Surgical pathology results (when available) on lesions positive on I-124 M5A but negative on standard imaging
Description
percent of patients with pathological confirmation of liver metastases
Time Frame
Up to 1 year
Title
I-124 identification of extra-hepatic lesions (both previously noted or new)
Description
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
Time Frame
Up to 1 year
Title
Incidence of adverse events
Description
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.
Time Frame
Up to 14 days post infusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Savita V Dandapani
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs