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

NCT05527483 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 32

Last updated 2024-05-16

No results posted yet for this 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.

Conditions

Interventions

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

Sponsors & Collaborators

  • University Hospitals Cleveland Medical Center

    lead OTHER

Principal Investigators

  • Robert Jones, M.D. · UH, Cleveland Medical Center

  • Norbert Avril, M.D. · UH, Cleveland Medical Center

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-21
Primary Completion
2022-10-10
Completion
2022-10-10
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05527483 on ClinicalTrials.gov