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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 is a Phase 1 study that was terminated before completion, run by Siemens Molecular Imaging. The registered enrollment target is 7 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01362712
The ClinicalTrials.gov registry entry for NCT01362712 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Siemens Molecular Imaging, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which [F18]CP-18 Injection is the first listed.
NCT01362712 reports 0 study locations.
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.
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