Spots Global Cancer Trial Database for Expanded Access Protocol of 68Ga-PSMA-11 for PET Imaging
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Trial Identification
Brief Title: Expanded Access Protocol of 68Ga-PSMA-11 for PET Imaging
Official Title: Expanded Access Protocol of 68Ga-PSMA-11 for Prostate Cancer PET Imaging
Study ID: NCT04348682
Conditions
Interventions
Study Description
Brief Summary: To provide expanded access to 68Ga-PSMA-11 PET imaging for eligible participants to detect and localize prostate cancer for initial and subsequent treatment strategy.
Detailed Description: Prostate-specific membrane antigen (PSMA) targeted Positron Emission Tomography (PET) imaging has been embraced enthusiastically worldwide. Given the unmet clinical need for accurately diagnosing and staging prostate cancer and the encouraging results of 68Ga-PSMA-11 PET worldwide, University of California Los Angeles (UCLA) and University of California San Francisco (UCSF) conducted pivotal registration trials to assess 68Ga-PSMA-11's safety and efficacy profile in detecting prostate cancer in adult patients. To gap the unmet clinical need of 68Ga-PSMA-11 PET during the period prior to FDA approval, UCLA Nuclear Medicine offers expanded access of this investigational PET drug to eligible participants.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
University of California at Los Angeles, Los Angeles, California, United States
Contact Details
Name: Jeremie Calais, M.D.
Affiliation: University of California at Los Angeles
Role: PRINCIPAL_INVESTIGATOR
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