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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [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. |
| |
| [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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [68Ga]PSMA | Drug | Patients will receive up to 6 mCi of [Ga-68]PSMA delivered as an intravenous (IV) bolus injection, followed by digital PET/CT imaging |
|
| Measure | Description | Time Frame |
|---|---|---|
| Uptake of [Ga-68]PSMA as measured by lesion by lesion analysis | Classified using a 5-point score with one being definitely metastatic and five being definitely benign | Up to 90 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Focally increased [Ga-68]PSMA uptake as measured by PET/CT | Up to 90 minutes |
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Inclusion Criteria:
Exclusion Criteria:
Male
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Members of all races and ethnic groups are eligible for this trial. Due to the nature of the disease, only people being diagnosed with prostate cancer are eligible.
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| Name | Affiliation | Role |
|---|---|---|
| Robert Jones, M.D. | UH, Cleveland Medical Center | Principal Investigator |
| Norbert Avril, M.D. | UH, Cleveland Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Case Comprehensive Cancer Center | Cleveland | Ohio | 44106 | United States |
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| Flourine-18 [F-18] Sodium Fluoride (NaF) | Drug | Patients will receive 8-12 mCi of [F-18]NaF delivered as an intravenous (IV) bolus injection, followed by digital PET/CT imaging. |
|
| PET/CT | Diagnostic Test | Patients will receive [68Ga]PSMA with a PET/CT and Flourine-18 [F-18] Sodium Fluoride (NaF) with a PET/CT |
|
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C000718244 | gallium 68 PSMA-11 |
| D012969 | Sodium Fluoride |
| D000072078 | Positron Emission Tomography Computed Tomography |
| ID | Term |
|---|---|
| D005459 | Fluorides |
| D006858 | Hydrofluoric Acid |
| D017611 | Fluorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D002327 | Cariostatic Agents |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D049268 | Positron-Emission Tomography |
| D014055 | Tomography, Emission-Computed |
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014057 | Tomography, X-Ray Computed |
| D064847 | Multimodal Imaging |
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D011877 | Radionuclide Imaging |
| D014054 | Tomography |
| D003947 | Diagnostic Techniques, Radioisotope |
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