Clinical trial · Observational
Digital PET/CT Using [Ga-68]PSMA vs. [F-18]NaF for Evaluation of Osseous Metastatic Involvement in Prostate Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [68Ga]PSMA | Drug | — | UNRESOLVED |
| Flourine-18 [F-18] Sodium Fluoride (NaF) | Drug | — | UNRESOLVED |
| PET/CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- [F-18]NaF
- description
- Patients will receive 8-12 mCi of \[F-18\]NaF delivered as an intravenous (IV) bolus injection, followed by digital PET/CT imaging.
- interventionNames
- Drug: [68Ga]PSMA
- Drug: Flourine-18 [F-18] Sodium Fluoride (NaF)
- Diagnostic Test: PET/CT
- label
- [Ga-68]PSMA
- description
- Patients will receive up to 6 mCi of \[Ga-68\]PSMA delivered as an intravenous (IV) bolus injection, followed by digital PET/CT imaging
- interventionNames
- Drug: [68Ga]PSMA
- Drug: Flourine-18 [F-18] Sodium Fluoride (NaF)
- Diagnostic Test: PET/CT
Primary outcomes (1)
- measure
- Uptake of [Ga-68]PSMA as measured by lesion by lesion analysis
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 1\) Patients must have a history of prostate cancer * 2\) Patients have known or highly suspected osseous metastatic involvement defined by the referring physician based on clinical history and/or findings from standard of care imaging. * 3\) Patients ≥ 18 years old * 4\) Patients able to tolerate PET/CT scans * 5\) Informed written consent must be given and signed Exclusion Criteria: * 1\. Subjects who do not meet the noted inclusion criteria * 2\. Patients \< 18 years old * 3\. Subjects who refuse to give or are unable to sign the informed consent * 4\. Anti-cancer treatment (chemotherapy and/or radiation therapy) within the last 2 weeks * 5\. Patients with a known allergy against Ga-68 PSMA or F-18 NaF
References
Publications (0)
Data not yet available