Fluciclovine-PET/CT for Bone Metastases From Prostate Adenocarcinoma
NCT ID: NCT03496844
Last Updated: 2022-08-16
Study Results
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View full resultsBasic Information
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COMPLETED
NA
15 participants
INTERVENTIONAL
2018-04-15
2021-04-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Routine F-18 fluciclovine-PET/CT scan
This arm will consist of prostate cancer patients who have had an F-18 fluciclovine-PET/CT scan for routine standard of care for biochemical recurrence. These patients would be asked to participate in the study only if there is a need for a standard of care bone biopsy.
No interventions assigned to this group
Research F-18 fluciclovine-PET/CT scan
This arm will consist of prostate cancer patients who would not ordinarily obtain an Axumin-PET scan for routine standard of care but have a need for bone biopsy. This will include patients with metastatic castrate resistant prostate cancer. For example, a patient with known lymph node recurrence of prostate cancer and suspicious finding on a bone scan would be asked to participate in the study and get a F-18 fluciclovine-PET/CT scan prior to the standard of care bone biopsy.
F-18 fluciclovine-PET/CT scan
PET/CT imaging with F-18 fluciclovine
Interventions
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F-18 fluciclovine-PET/CT scan
PET/CT imaging with F-18 fluciclovine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Be ≥ 18 years of age
3. Diagnosed with prostate cancer
4. Be willing and able to provide informed consent
5. Be informed of the investigational nature of this study
Exclusion Criteria
2. Weight exceeding 400lbs
18 Years
MALE
No
Sponsors
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Blue Earth Diagnostics
INDUSTRY
Banner University Medical Center
OTHER
University of Arizona
OTHER
Responsible Party
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Principal Investigators
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Phillip H Kuo, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Arizona
Hani Babiker, MD
Role: PRINCIPAL_INVESTIGATOR
University of Arizona
Locations
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University of Arizona
Tucson, Arizona, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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1803340164
Identifier Type: -
Identifier Source: org_study_id
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