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NCT04149353 · ClinicalTrials.gov registry record · NA
PET/MR in Surgical Planning for Breast CA Treated With Neoadj Chemo
A NA study, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Terminated
- Registry status
- NA
- Development phase
- 1
- Enrollment target
NCT04149353: Clinical Trial NA study, sponsored by UNC Lineberger Comprehensive Cancer Center.
NCT04149353 is a NA study that was terminated before completion, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 1 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04149353, a NA study, was terminated before completion, sponsored by UNC Lineberger Comprehensive Cancer Center.
- TERMINATED
- Registry status
- NA
- Development phase
- 1 participants
- Enrollment target
Study Summary
Purpose: To assess the utility of combined, simultaneous positron emission tomography (PET) and magnetic resonance imaging (MRI), collectively called PET-MR, in assessing response to neoadjuvant chemotherapy and surgical treatment decisions for operable breast cancers. Participants: Adult patients with operable breast cancer that are being treated at UNC with neoadjuvant chemotherapy followed by potentially curative surgical resection. Procedures (methods): Patients who are being treated with neoadjuvant chemotherapy followed by surgical resection and for whom pre- and post-treatment MR imaging is part of planned treatment will undergo additional pre-treatment and post-treatment PET/MR. The response to treatment will be assessed at post-treatment by evaluating change in tumor size from MRI, change in response to dynamic contrast enhanced (DCE) MRI, and 18F-fluorodeoxyglucose (18F-FDG) avidity from PET. Patients will then undergo surgery. Their pathology will be reviewed for treatment effect as assessed by residual cancer burden (RCB) score. Patients will be followed and assessed for recurrence.
Primary Outcome
Primary endpoint is the determination of the potential for PET activity estimates to predict RCB score in comparison with that of dynamic contrast enhanced (DCE) MRI. Treatment response will be determined on final pathological evaluation of the resected specimens by way of the RCB score.
Interventions
- DIAGNOSTIC_TEST PET/MR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2018-12-05 |
| Est. Completion | 2020-02-17 |
| Phase | NA |
Why NCT04149353 stopped before completion
NCT04149353 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which PET/MR is the first listed.
NCT04149353 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04149353 about?
NCT04149353 is a clinical study titled "PET/MR in Surgical Planning for Breast CA Treated With Neoadj Chemo". Purpose: To assess the utility of combined, simultaneous positron emission tomography (PET) and magnetic resonance imaging (MRI), collectively called PET-MR, in assessing response to neoadjuvant chemotherapy and surgical treatment decisions for operable breast cancers. Participants: Adult patients ...
What is the current status of trial NCT04149353?
This trial is currently terminated. It is a NA study. The enrollment target is 1 participants. The study started on 2018-12-05. Estimated completion is 2020-02-17.
What interventions are being tested in trial NCT04149353?
The interventions under investigation include: PET/MR (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04149353?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04149353's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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