Digital PET/CT Using [Ga-68]PSMA vs. [F-18]NaF for Evaluation of Osseous Metastatic Involvement in Prostate Cancer Patients
NCT ID: NCT05527483
Last Updated: 2024-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
32 participants
OBSERVATIONAL
2022-04-21
2022-10-10
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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[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.
[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
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.
PET/CT
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
[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
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.
PET/CT
Patients will receive \[68Ga\]PSMA with a PET/CT and Flourine-18 \[F-18\] Sodium Fluoride (NaF) with a PET/CT
Interventions
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[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
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.
PET/CT
Patients will receive \[68Ga\]PSMA with a PET/CT and Flourine-18 \[F-18\] Sodium Fluoride (NaF) with a PET/CT
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
MALE
No
Sponsors
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University Hospitals Cleveland Medical Center
OTHER
Responsible Party
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Norbert Avril
Division Chief, Nuclear Medicine
Principal Investigators
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Robert Jones, M.D.
Role: PRINCIPAL_INVESTIGATOR
UH, Cleveland Medical Center
Norbert Avril, M.D.
Role: PRINCIPAL_INVESTIGATOR
UH, Cleveland Medical Center
Locations
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Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Countries
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Other Identifiers
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STUDY20220121
Identifier Type: -
Identifier Source: org_study_id
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