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NCT01362712 · ClinicalTrials.gov registry record · Phase 1
Exploratory, Phase I,Open Label,Non-randomized Study of [F18]CP-18 PET in Normal and Breast Cancer Subjects
A Phase 1 study, sponsored by Siemens Molecular Imaging.
- Terminated
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
NCT01362712: Clinical Trial Phase 1 study, sponsored by Siemens Molecular Imaging.
NCT01362712 is a Phase 1 study that was terminated before completion, run by Siemens Molecular Imaging. The registered enrollment target is 7 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01362712, a Phase 1 study, was terminated before completion, sponsored by Siemens Molecular Imaging.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
Study Summary
This trial will be the first trial for the IP, \[F-18\]CP-18, and will be conducted as an exploratory Phase I trial designed to collect information as this IP is administered and evaluated for the first time in humans. The trial will evaluate safety, biodistribution and dosimetry data in normal subjects and the trial will evaluate safety, biodistribution and tumor to background imaging data, and correlate image data with caspase 3 activity level on a surgical specimen analyzed by immunohistochemistry in the cancer subjects. All study results will be evaluated and analyzed in order to consider the design for future clinical trials. The information collected under this exploratory, Phase I study will not be used for diagnostic purposes, to assess the subject's response to therapy, or for clinical management of the subject.
Interventions
- RADIATION [F18]CP-18 Injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2011-05 |
| Est. Completion | 2012-04 |
| Phase | Phase 1 |
Why NCT01362712 stopped before completion
NCT01362712 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 1 intervention - of which [F18]CP-18 Injection is the first listed.
NCT01362712 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01362712 about?
NCT01362712 is a clinical study titled "Exploratory, Phase I,Open Label,Non-randomized Study of [F18]CP-18 PET in Normal and Breast Cancer Subjects". This trial will be the first trial for the IP, \[F-18\]CP-18, and will be conducted as an exploratory Phase I trial designed to collect information as this IP is administered and evaluated for the first time in humans. The trial will evaluate safety, biodistribution and dosimetry data in normal subj...
What is the current status of trial NCT01362712?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2011-05. Estimated completion is 2012-04.
What interventions are being tested in trial NCT01362712?
The interventions under investigation include: [F18]CP-18 Injection (RADIATION).
Who is sponsoring clinical trial NCT01362712?
This trial is sponsored by Siemens Molecular Imaging, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01362712's enrollment target sits among peer trials
7 1972nd of 2000 higher than 27 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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