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, 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44106
- Case Comprehensive Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
[F-18]NaF
Patients will receive 8-12 mCi of [F-18]NaF delivered as an intravenous (IV) bolus injection, followed by digital PET/CT imaging.
|
Patients will receive up to 6 mCi of [Ga-68]PSMA delivered as an intravenous (IV) bolus injection, followed by digital PET/CT imaging
Patients will receive 8-12 mCi of [F-18]NaF delivered as an intravenous (IV) bolus injection, followed by digital PET/CT imaging.
Patients will receive [68Ga]PSMA with a PET/CT and Flourine-18 [F-18] Sodium Fluoride (NaF) with a PET/CT
|
|
[Ga-68]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
|
Patients will receive up to 6 mCi of [Ga-68]PSMA delivered as an intravenous (IV) bolus injection, followed by digital PET/CT imaging
Patients will receive 8-12 mCi of [F-18]NaF delivered as an intravenous (IV) bolus injection, followed by digital PET/CT imaging.
Patients will receive [68Ga]PSMA with a PET/CT and Flourine-18 [F-18] Sodium Fluoride (NaF) with a PET/CT
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Uptake of [Ga-68]PSMA as measured by lesion by lesion analysis
Time Frame: Up to 90 minutes
|
Classified using a 5-point score with one being definitely metastatic and five being definitely benign
|
Up to 90 minutes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Focally increased [Ga-68]PSMA uptake as measured by PET/CT
Time Frame: Up to 90 minutes
|
Up to 90 minutes
|
Collaborators and Investigators
Investigators
- Principal Investigator: Robert Jones, M.D., UH, Cleveland Medical Center
- Principal Investigator: Norbert Avril, M.D., UH, Cleveland Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Urogenital Diseases
- Male Urogenital Diseases
- Genital Diseases, Male
- Genital Diseases
- Prostatic Neoplasms
- Physiological Effects of Drugs
- Anti-Infective Agents, Local
- Anti-Infective Agents
- Protective Agents
- Cariostatic Agents
- Listerine
- Fluorides
- Sodium Fluoride
Other Study ID Numbers
- STUDY20220121
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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