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NCT04377152 Clinical Trial

Expanded Access 68Gallium-PSMA-11 PET for Prostate Cancer

Prostate Cancer Clinical Trial

Official title:
Expanded Access: 68Gallium-PSMA-11 for PET Imaging of Prostate Cancer

Clinical Trial Details — Status: Approved for marketing

Administrative data
NCT number NCT04377152
Other study ID # EA-HOPE20200129
Secondary ID 20-30046
Status Approved for marketing
Phase
First received
Last updated

Study information
Verified date February 2021
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial Summary

This expanded access protocol provides eligible participants with investigational 68Ga-PSMA-11 PET imaging to detect and localize prostate cancer for initial and subsequent treatment strategy.

Recruitment information / eligibility
Status Approved for marketing
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Male
Age group 18 Years and older
Eligibility Biochemical recurrent and pre-prostatectomy staging participants will be eligible and must meet the following criteria: Inclusion Criteria: 1. Age = 18 years 2. Histopathologically confirmed or biopsy proven prostate adenocarcinoma. 3. Concern for metastatic disease in one of the following settings: 1. Initial staging with intermediate to high risk prostate cancer. 2. Biochemical recurrence after initial therapy. 4. Ability to understand a written informed consent document, and the willingness to sign it Exclusion Criteria: 1. Unlikely to comply with protocol procedures, restrictions and requirements and judged by the Investigator to be unsuitable for participation

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 68Gallium-PSMA-11
PSMA-11 Ga 68 Injection is a positron emitting radiopharmaceutical containing radioactive 68Ga-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC (PSMA-11), which is used for diagnostic purposes in conjunction with Positron Emission Tomography (PET).
Procedure:
• Positron Emission Tomography (PET)
A PET scan is an imaging test that helps reveal how your tissues and organs are functioning using a radioactive drug (tracer) to show this activity

Locations
Country Name City State
United States University of California, San Francisco San Francisco California

Sponsors (1)
Lead Sponsor Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

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