An Imaging Agent (I-124 M5A) in Detecting CEA-Positive Liver Metastases in Patients With Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT03993327|
Recruitment Status : Not yet recruiting
First Posted : June 20, 2019
Last Update Posted : October 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|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||Biological: Iodine I 124 Monoclonal Antibody M5A Procedure: Positron Emission Tomography||Phase 1|
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.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study: Detection of Colorectal Metastatic Liver Disease Preoperatively Using 124I-Labeled M5A Monoclonal Antibody to Carcinoembryonic Antigen (CEA)|
|Estimated Study Start Date :||December 1, 2019|
|Estimated Primary Completion Date :||June 8, 2021|
|Estimated Study Completion Date :||June 8, 2021|
Experimental: Diagnostic (iodine I 124 monoclonal antibody M5A, PET scan)
Patients receive iodine I 124 monoclonal antibody M5A IV on day 0 and undergo PET scan on days 2 and 6.
Biological: Iodine I 124 Monoclonal Antibody M5A
Procedure: Positron Emission Tomography
Undergo PET scan
- 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 ]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 [ Time Frame: Up to 1 year ]
- Surgical results (when available per standard of care surgery/pathology) on lesions negative on I-124 M5A but positive on standard scans [ Time Frame: Up to 1 year ]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 [ Time Frame: Up to 1 year ]
- Surgical pathology results (when available) on lesions positive on I-124 M5A but negative on standard imaging [ Time Frame: Up to 1 year ]percent of patients with pathological confirmation of liver metastases
- I-124 identification of extra-hepatic lesions (both previously noted or new) [ Time Frame: Up to 1 year ]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 [ Time Frame: Up to 14 days post infusion ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03993327
|United States, California|
|City of Hope Medical Center||Not yet recruiting|
|Duarte, California, United States, 91010|
|Contact: Savita V. Dandapani firstname.lastname@example.org|
|Principal Investigator: Savita V. Dandapani|
|Principal Investigator:||Savita V Dandapani||City of Hope Medical Center|