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NCT02103634 · ClinicalTrials.gov registry record
NaF PET/MRI Evaluation for Bone Metastases in Breast Cancer
A clinical trial, sponsored by Case Comprehensive Cancer Center.
- Completed
- Registry status
- 29
- Enrollment target
NCT02103634: Completed study, sponsored by Case Comprehensive Cancer Center.
NCT02103634 is a clinical trial that has completed, run by Case Comprehensive Cancer Center. The registered enrollment target is 29 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02103634 has completed, sponsored by Case Comprehensive Cancer Center.
- COMPLETED
- Registry status
- 29 participants
- Enrollment target
Study Summary
This study will look at two new technologies being developed for measuring cancer in bones. One of these technologies is a substance called Sodium Fluoride (NaF). Fluoride is a normal body substance. The amount that patients will receive has been shown to be very safe. One study of over 400 patients showed no adverse reactions after receiving the recommended dosage. NaF (known as a radiotracer) is taken up into the bones under a normal process and researchers can measure the amount within patient's bones through an imaging system called a Positron Emission Tomography/Magnetic Resonance Imaging (PET/MRI). This system combines aspects of both a PET study as part of the regular standard of care and an MRI study. The belief is that the combination of these two studies will be better than either study alone.People who have enrolled in this study will receive their clinically requested PET/CT scan as part of their normal diagnostic care and will follow all the said recommendations for this study such as not being pregnant, having fasted overnight, etc. Subjects will return within 7 days for a 10 mCi NaF PET/MRI study. The patients' imaging time will be up to 120 minutes depending on the MRI sequences acquired. Imaging for the PET portion of the study will take approximately 20-30 minutes with the rest of the time devoted to MRI sequences.
Primary Outcome
The difference in the number of lesions detected by the two imaging methods using McNamar's test
Interventions
- DEVICE NaF PET/MRI
- DEVICE NaF PET/CT
- DEVICE FDG PET/CT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2014-03-01 |
| Est. Completion | 2018-12-21 |
What the finished NCT02103634 record still lists
NCT02103634 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 29 participants, a relatively small participant target.
The record links to 0 conditions, and to 3 interventions - of which NaF PET/MRI is the first listed.
NCT02103634 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02103634 about?
NCT02103634 is a clinical study titled "NaF PET/MRI Evaluation for Bone Metastases in Breast Cancer". This study will look at two new technologies being developed for measuring cancer in bones. One of these technologies is a substance called Sodium Fluoride (NaF). Fluoride is a normal body substance. The amount that patients will receive has been shown to be very safe. One study of over 400 patients...
What is the current status of trial NCT02103634?
This trial is currently completed. The enrollment target is 29 participants. The study started on 2014-03-01. Estimated completion is 2018-12-21.
What interventions are being tested in trial NCT02103634?
The interventions under investigation include: NaF PET/MRI (DEVICE), NaF PET/CT (DEVICE), FDG PET/CT (DEVICE).
Who is sponsoring clinical trial NCT02103634?
This trial is sponsored by Case Comprehensive Cancer Center, which has 407 total clinical trials registered on ClinicalTrials.gov.
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