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NCT03542695 · ClinicalTrials.gov registry record · Early Phase 1
64 Cu-DOTA-alendronate PET Imaging in Localizing and Characterizing Breast Calcifications in Participants Before Undergoing Mastectomy
A Early Phase 1 study, sponsored by City of Hope Medical Center.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 1
- Enrollment target
NCT03542695: Completed Early Phase 1 study, sponsored by City of Hope Medical Center.
NCT03542695 is a Early Phase 1 study that has completed, run by City of Hope Medical Center. The registered enrollment target is 1 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03542695, a Early Phase 1 study, has completed, sponsored by City of Hope Medical Center.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
This early phase I pilot trial studies how well 64Cu-DOTA-alendronate positron emission tomography (PET) imaging work in localizing and characterizing breast calcifications (small calcium deposits) in participants before undergoing mastectomy. Diagnostic procedures, such 64Cu-DOTA-alendronate PET, may detect calcification and help doctors predict cancer associated calcification within breast tissue.
Primary Outcome
Tumor size sensitivity and the ability to detect calcifications will be compared to the extent of calcifications seen on mammogram.
Interventions
- PROCEDURE Computed Tomography
- PROCEDURE Positron Emission Tomography
- OTHER Pharmacokinetic Study
- DRUG Copper Cu-64-DOTA-alendronate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2021-11-03 |
| Est. Completion | 2024-05-31 |
| Phase | Early Phase 1 |
What the finished NCT03542695 record still lists
NCT03542695 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 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 4 interventions - of which Computed Tomography is the first listed.
NCT03542695 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03542695 about?
NCT03542695 is a clinical study titled "64 Cu-DOTA-alendronate PET Imaging in Localizing and Characterizing Breast Calcifications in Participants Before Undergoing Mastectomy". This early phase I pilot trial studies how well 64Cu-DOTA-alendronate positron emission tomography (PET) imaging work in localizing and characterizing breast calcifications (small calcium deposits) in participants before undergoing mastectomy. Diagnostic procedures, such 64Cu-DOTA-alendronate PET, m...
What is the current status of trial NCT03542695?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 1 participants. The study started on 2021-11-03. Estimated completion is 2024-05-31.
What interventions are being tested in trial NCT03542695?
The interventions under investigation include: Computed Tomography (PROCEDURE), Positron Emission Tomography (PROCEDURE), Pharmacokinetic Study (OTHER), Copper Cu-64-DOTA-alendronate (DRUG).
Who is sponsoring clinical trial NCT03542695?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03542695's enrollment target sits among peer trials
1 1986th of 2000 the lowest of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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