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Digital PET/CT Using [Ga-68]PSMA for Characterization of Prostate Lesions

NCT ID: NCT04867603

Last Updated: 2023-12-19

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-29

Study Completion Date

2022-10-03

Brief Summary

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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 characterization of prostate abnormalities.

Detailed Description

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Individuals with clinical suspicion of prostate cancer and without prior prostate biopsy are offered abbreviated bi-parametric prostate MRI. As Standard of Care (SOC), MRIs will be examined and scored for likelihood for malignancy using the PI-RADS version 2.1 criteria. Those with PI-RADS 3, 4 or 5 lesions or those with PI-RADS 1 or 2 lesions with clinical suspicion for prostate cancer based on serum PSA level, family history or clinical examination (positive digital rectal examination) will be included on study. Only those receiving care at University Hospitals Cleveland Medical Center will be included into the study.

This study is to evaluate (\[Ga-68\]PSMA) for characterization of prostate abnormalities. For imaging, an FDA approved imaging technology, digital Positron Emission Tomography (PET/CT) will be used. The study team would like to know if digital PET/CT using \[Ga-68\]PSMA provides accurate information whether or not a participant has prostate cancer and if there is potential spread of the disease within the body. \[Ga-68\]PSMA is an investigational (experimental) drug that works by binding to Prostate Specific Membrane Antigen (PSA), which is overexpressed in prostate cancer. \[Ga-68\]PSMA is experimental because it is not approved by the Food and Drug Administration (FDA). However, FDA approval has been obtained for this study protocol by an Investigational New Drug (IND) application.

Conditions

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Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Digital PET/CT using [Ga-68]PSMA

Following prostate Standard of Care MRI, eligible participants will receive a single injection of \[Ga-68\]PSMA followed by digital PET/CT imaging approximately 60 minutes later. PET/CT takes approximately 30-35 minutes, where the participant would lay still on a scanner table.

[Ga-68]PSMA

Intervention Type DRUG

The injectable activity will be a maximum of 210 MBq (6.0 mCi) \[Ga-68\]PSMA at the time of injection and is administered to subjects by intravenous injection.

PET/CT imaging

Intervention Type DEVICE

PET/CT imaging procedure

Interventions

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[Ga-68]PSMA

The injectable activity will be a maximum of 210 MBq (6.0 mCi) \[Ga-68\]PSMA at the time of injection and is administered to subjects by intravenous injection.

Intervention Type DRUG

PET/CT imaging

PET/CT imaging procedure

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients who have a clinical suspicion of prostate cancer defined by PI-RADS 3, 4 or 5 lesions detected on MRI as well as patients with negative prostate MRI or those with PI-RADS 1 or 2 lesions if they have continued suspicion for prostate cancer. Patients who cannot undergo MRI imaging but have a clinical suspicion for prostate cancer based on serum PSA level, family history or clinical examination (positive digital rectal examination) can also be included.
* Able to tolerate PET/CT scans
* Informed consent must be given and signed

Exclusion Criteria

* Anti-cancer treatment (chemotherapy and/or radiation therapy) within the last 2 weeks
* Known allergy against Ga-68 PSMA
* Prior prostate biopsy within the last 2 weeks
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Norbert Avril, M.D.

OTHER

Sponsor Role lead

Responsible Party

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Norbert Avril, M.D.

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Norbert Avril, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Locations

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University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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CASE1821

Identifier Type: -

Identifier Source: org_study_id