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NCT05245786 · ClinicalTrials.gov registry record · Early Phase 1
An Investigational Scan (64Cu-Labeled M5A Antibody) in Combination With SOC Chemotherapy and Radiotherapy in Locally Advanced Rectal Cancer
A Early Phase 1 study of Stage III Rectal Cancer AJCC v8 and Stage IIIA Rectal Cancer AJCC v8, sponsored by City of Hope Medical Center.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT05245786: Recruiting Early Phase 1 study of Stage III Rectal Cancer AJCC v8 and Stage IIIA Rectal Cancer AJCC v8, sponsored by City of Hope Medical Center.
NCT05245786 is a Early Phase 1 study of Stage III Rectal Cancer AJCC v8 and Stage IIIA Rectal Cancer AJCC v8 that is actively recruiting participants, run by City of Hope Medical Center. The registered enrollment target is 15 participants, below the 116-participant average among 15 other Stage III Rectal Cancer AJCC v8 trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05245786, a Early Phase 1 study of Stage III Rectal Cancer AJCC v8 and Stage IIIA Rectal Cancer AJCC v8, is actively recruiting participants, sponsored by City of Hope Medical Center.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
This early phase I trial investigates how well 64Cu-labeled M5A antibody scan works in assessing tumor activity before and after patients with rectal cancer that has spread to nearby tissue or lymph nodes (locally advanced) who are undergoing chemotherapy and radiotherapy. Using 64Cu-labeled M5A positron emission tomography imaging may play a significant role in imaging patients with colorectal cancer.
Primary Outcome
We seek to evaluate the potential for 64Cu-M5A PET imaging in locally advanced rectal cancer before and after neoadjuvant radio-chemotherapy yet prior to planned surgery. Scan findings will be compared to standard of care imaging studies (eg. CT, MRI and FDG PET scans) and biopsy and findings from endoscopy and surgery performed post neoadjuvant CRT therapy. Each of the 15 cases will be reviewed in a protocol team meeting consisting of a radiologist, radiation oncologist, surgeon and pathologist
Conditions Studied
Interventions
- PROCEDURE Imaging Technique
- BIOLOGICAL Copper Cu 64 Anti-CEA Monoclonal Antibody M5A
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2022-08-31 |
| Est. Completion | 2026-11-12 |
| Phase | Early Phase 1 |
What NCT05245786 shows while recruiting
NCT05245786 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 116-participant average among 15 other Stage III Rectal Cancer AJCC v8 trials with a reported enrollment target (87% lower).
The record links to 5 conditions, with Stage III Rectal Cancer AJCC v8 appearing as the primary indexed condition, and to 2 interventions - of which Imaging Technique is the first listed.
NCT05245786 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05245786 about?
NCT05245786 is a clinical study titled "An Investigational Scan (64Cu-Labeled M5A Antibody) in Combination With SOC Chemotherapy and Radiotherapy in Locally Advanced Rectal Cancer". This early phase I trial investigates how well 64Cu-labeled M5A antibody scan works in assessing tumor activity before and after patients with rectal cancer that has spread to nearby tissue or lymph nodes (locally advanced) who are undergoing chemotherapy and radiotherapy. Using 64Cu-labeled M5A pos...
What is the current status of trial NCT05245786?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 15 participants. The study started on 2022-08-31. Estimated completion is 2026-11-12.
What conditions does trial NCT05245786 study?
This clinical trial studies the following conditions: Stage III Rectal Cancer AJCC v8, Stage IIIA Rectal Cancer AJCC v8, Stage IIIB Rectal Cancer AJCC v8, Stage IIIC Rectal Cancer AJCC v8, Locally Advanced Rectal Carcinoma.
What interventions are being tested in trial NCT05245786?
The interventions under investigation include: Imaging Technique (PROCEDURE), Copper Cu 64 Anti-CEA Monoclonal Antibody M5A (BIOLOGICAL).
Who is sponsoring clinical trial NCT05245786?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05245786 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 NCT05245786's enrollment target sits among peer trials
15 15th of 15 higher than 1 of 15 other Stage III Rectal Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage III Rectal Cancer AJCC v8 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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