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NCT05527483 · ClinicalTrials.gov registry record
Digital PET/CT Using [Ga-68]PSMA vs. [F-18]NaF for Evaluation of Osseous Metastatic Involvement in Prostate Cancer Patients
A clinical trial, sponsored by University Hospitals Cleveland Medical Center.
- Completed
- Registry status
- 32
- Enrollment target
NCT05527483: Completed study, sponsored by University Hospitals Cleveland Medical Center.
NCT05527483 is a clinical trial that has completed, run by University Hospitals Cleveland Medical Center. The registered enrollment target is 32 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05527483 has completed, sponsored by University Hospitals Cleveland Medical Center.
- COMPLETED
- Registry status
- 32 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate a radioactive diagnostic study drug, which is called Gallium-68 Prostate Specific Membrane Antigen (\[Ga-68\]PSMA) for detection of bone metastasis in patients with prostate cancer. For imaging the investigators will use a FDA approved imaging technology, digital Positron Emission Tomography (PET/CT). The investigators would like to know if digital PET/CT using \[Ga-68\]PSMA provides accurate information about the extent of bone metastases. Therefore, the investigators will compare\[Ga-68\]PSMA PET/CT with Flourine-18 \[F-18\] Sodium Fluoride (NaF), which is a high resolution bone scan. \[F-18\]NaF is FDA approved and the reference standard for evaluating the presence of bone metastases.\[Ga-68\]PSMA is an investigational (experimental) drug that works by binding to Prostate Specific Membrane Antigen, which is overexpressed in prostate cancer. \[Ga-68\]PSMA is experimental because it is not approved by the Food and Drug Administration (FDA) at University Hospitals. However, FDA approval has been obtained for this study protocol by an Investigational New Drug (IND) application.
Primary Outcome
Classified using a 5-point score with one being definitely metastatic and five being definitely benign
Interventions
- DIAGNOSTIC_TEST PET/CT
- DRUG [68Ga]PSMA
- DRUG Flourine-18 [F-18] Sodium Fluoride (NaF)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2022-04-21 |
| Est. Completion | 2022-10-10 |
What the finished NCT05527483 record still lists
NCT05527483 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 32 participants, a relatively small participant target.
The record links to 0 conditions, and to 3 interventions - of which PET/CT is the first listed.
NCT05527483 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05527483 about?
NCT05527483 is a clinical study titled "Digital PET/CT Using [Ga-68]PSMA vs. [F-18]NaF for Evaluation of Osseous Metastatic Involvement in Prostate Cancer Patients". The purpose of this study is to evaluate a radioactive diagnostic study drug, which is called Gallium-68 Prostate Specific Membrane Antigen (\[Ga-68\]PSMA) for detection of bone metastasis in patients with prostate cancer. For imaging the investigators will use a FDA approved imaging technology, di...
What is the current status of trial NCT05527483?
This trial is currently completed. The enrollment target is 32 participants. The study started on 2022-04-21. Estimated completion is 2022-10-10.
What interventions are being tested in trial NCT05527483?
The interventions under investigation include: PET/CT (DIAGNOSTIC_TEST), [68Ga]PSMA (DRUG), Flourine-18 [F-18] Sodium Fluoride (NaF) (DRUG).
Who is sponsoring clinical trial NCT05527483?
This trial is sponsored by University Hospitals Cleveland Medical Center, which has 230 total clinical trials registered on ClinicalTrials.gov.
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