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NCT03993327 · ClinicalTrials.gov registry record · Phase 1
An Imaging Agent (I-124 M5A) in Detecting CEA-Positive Liver Metastases in Patients With Colorectal Cancer
A Phase 1 study of Metastatic Colorectal Carcinoma and Stage IV Colorectal Cancer AJCC v8, sponsored by City of Hope Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
- 1
- Study location
NCT03993327: Completed Phase 1 study of Metastatic Colorectal Carcinoma and Stage IV Colorectal Cancer AJCC v8, sponsored by City of Hope Medical Center.
NCT03993327 is a Phase 1 study of Metastatic Colorectal Carcinoma and Stage IV Colorectal Cancer AJCC v8 that has completed, run by City of Hope Medical Center. The registered enrollment target is 4 participants, below the 89-participant average among 22 other Metastatic Colorectal Carcinoma trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03993327, a Phase 1 study of Metastatic Colorectal Carcinoma and Stage IV Colorectal Cancer AJCC v8, has completed, sponsored by City of Hope Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- PROCEDURE Positron Emission Tomography
- BIOLOGICAL Iodine I 124 Monoclonal Antibody M5A
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2020-07-15 |
| Est. Completion | 2024-06-04 |
| Phase | Phase 1 |
What the finished NCT03993327 record still lists
NCT03993327 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 89-participant average among 22 other Metastatic Colorectal Carcinoma trials with a reported enrollment target (96% lower).
The record links to 6 conditions, with Metastatic Colorectal Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Positron Emission Tomography is the first listed.
NCT03993327 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03993327 about?
NCT03993327 is a clinical study titled "An Imaging Agent (I-124 M5A) in Detecting CEA-Positive Liver Metastases in Patients With Colorectal Cancer". 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, throug...
What is the current status of trial NCT03993327?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2020-07-15. Estimated completion is 2024-06-04.
What conditions does trial NCT03993327 study?
This clinical trial studies the following conditions: 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.
What interventions are being tested in trial NCT03993327?
The interventions under investigation include: Positron Emission Tomography (PROCEDURE), Iodine I 124 Monoclonal Antibody M5A (BIOLOGICAL).
Who is sponsoring clinical trial NCT03993327?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03993327 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03993327's enrollment target sits among peer trials
4 23rd of 22 the lowest of 22 other Metastatic Colorectal Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Colorectal Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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