NCT05527483

Digital PET/CT Using [Ga-68]PSMA vs. [F-18]NaF for Evaluation of Osseous Metastatic Involvement in Prostate Cancer Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 32 (actual)
• Sponsor: University Hospitals Cleveland Medical Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	[68Ga]PSMA	Patients will receive up to 6 mCi of \[Ga-68\]PSMA delivered as an intravenous (IV) bolus injection, followed by digital PET/CT imaging
DRUG	Flourine-18 [F-18] Sodium Fluoride (NaF)	Patients will receive 8-12 mCi of \[F-18\]NaF delivered as an intravenous (IV) bolus injection, followed by digital PET/CT imaging.
DIAGNOSTIC_TEST	PET/CT	Patients will receive \[68Ga\]PSMA with a PET/CT and Flourine-18 \[F-18\] Sodium Fluoride (NaF) with a PET/CT

Timeline

• Start date: 2022-04-21
• Primary completion: 2022-10-10
• Completion: 2022-10-10
• First posted: 2022-09-02
• Last updated: 2024-05-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study