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NCT01240551 · ClinicalTrials.gov registry record · Phase 2
F-18 Sodium Fluoride in Prostate Cancer
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
NCT01240551: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT01240551 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 60 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01240551, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
Study Summary
Background: \- Sodium fluoride (NaF) is a common compound that is found in various foods and can be used to increase bone strength. When this compound is added to a small dose of radiation (F-18), it collects in the bones, with higher amounts in areas where the bone is rapidly changing, such as the site of a healing fracture or a tumor. By giving F-18 NaF before a combined positron emission tomography/ computed tomography (PET/CT) scan, researchers hope to be able to better measure the changes in the bone that may indicate that a certain type of cancer (such as prostate cancer) has spread to the bones. Objectives: * To evaluate the effectiveness of F-18 NaF in imaging studies to measure bone tumors and their change over time and compare with clinical course, in individuals with prostate cancer. * To determine the smallest amount of change in the bone tumors that F-18 NaF can accurately measure. Eligibility: \- Men at least 18 years of age who have been diagnosed with prostate cancer and have had imaging studies to determine whether the cancer has spread to their bones. Both patients with and without known bone involvement will be enrolled. Design: * Participants will be screened with a physical examination, medical history, and imaging studies, and will provide baseline blood samples to evaluate kidney function. * For the study, participants will have two F-18 NaF PET/CT scans on separate days for baseline. These repeat scans will be used to determine the amount of change that is due to the imaging process alone (i.e. not due to the disease getting better or worse. Participants will receive a dose of F-18 NaF intravenously, and will have PET/CT scanning over the body (mid ear to upper thighs) over 1 hour, the body followed by a complete whole-body PET/CT scan at approximately 2 hours after F-18 NaF injection. Participants will be watched closely for side effects from the F-18 NaF until the scans are done, and will be asked to drink plenty of water to void the
Primary Outcome
Present and not present bone metastasis was determined by sodium fluoride (NaF) PET (positron emission imaging)/CT (computed tomography) imaging. Present bone metastasis is defined as greater than normal bone uptake. Not present bone metastasis is defined as physiological bone uptake of F-18 NaF on PET/CT imaging (i.e. excluding traumatic and degenerative foci of increased F-18 NaF uptake.
Interventions
- DRUG F-18 NaF
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2010-11-30 |
| Est. Completion | 2013-05-31 |
| Phase | Phase 2 |
What the finished NCT01240551 record still lists
NCT01240551 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 1 intervention - of which F-18 NaF is the first listed.
NCT01240551 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01240551 about?
NCT01240551 is a clinical study titled "F-18 Sodium Fluoride in Prostate Cancer". Background: \- Sodium fluoride (NaF) is a common compound that is found in various foods and can be used to increase bone strength. When this compound is added to a small dose of radiation (F-18), it collects in the bones, with higher amounts in areas where the bone is rapidly changing, such as the...
What is the current status of trial NCT01240551?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2010-11-30. Estimated completion is 2013-05-31.
What interventions are being tested in trial NCT01240551?
The interventions under investigation include: F-18 NaF (DRUG).
Who is sponsoring clinical trial NCT01240551?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01240551's enrollment target sits among peer trials
60 1027th of 2000 higher than 868 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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