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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-01923 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 18386 | Other Identifier | City of Hope Medical Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (iodine I 124 monoclonal antibody M5A, PET scan) | Experimental | Patients receive iodine I 124 monoclonal antibody M5A IV on day 0 and undergo PET scan on days 2 and 6. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iodine I 124 Monoclonal Antibody M5A | Biological | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Days 0, 2, and 6 drawn at approximately 1 hour, 2 hour and 3-4 hours post-end of infusion |
| Percent of known liver lesions per standard staging scans identified on iodine I-124 (I-124) M5A imaging | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 1 year |
| Percent of patients with suspicious liver lesions identified on I-124 M5A but were not identified on standard imaging |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Savita V Dandapani | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | United States |
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| Positron Emission Tomography | Procedure | Undergo PET scan |
|
|
| Up to 1 year |
| 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 | Up to 1 year |
| 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 | Up to 1 year |
| 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. | Up to 14 days post infusion |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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