68Ga-PSMA PET-CT Scan for Diagnosis and Management of Prostate Cancer
NCT02282137 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 208
Last updated 2020-08-19
Summary
This is a phase II clinical trial study to show how well the 68Ga-PSMA-11 (ProstaMedix™) PET-CT scan works in detecting tumor location and size in patients with suspected or confirmed prostate cancer, as well as prostate cancer that may have come back in patients with elevated PSA ( a prostate-specific antigen tumor marker) after initial treatment.
Conditions
Interventions
- DRUG
-
68Ga-PSMA
Patients with suspected prostate cancer recurrence and non-informative bone scintigraphy, computerized tomography (CT) or magnetic resonance imaging (MRI). Suspected prostate recurrence is based upon elevated blood prostate specific antigen (PSA) levels following initial therapy.
Sponsors & Collaborators
-
Radiomedix, Inc.
collaborator INDUSTRY -
Excel Diagnostics and Nuclear Oncology Center
collaborator OTHER -
Ebrahim Delpassand
lead OTHER
Principal Investigators
-
Rodolfo Nunez, MD · Excel Diagnostics and Nuclear Oncology Center
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-05-31
- Primary Completion
- 2022-12-31
- Completion
- 2023-12-31
Countries
- United States
Study Locations
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