Prostate Neoplasm Clinical Trial
Official title:
Pilot Feasibility Study of 18F-FMAU PET for Diagnosing and Characterizing Prostate Cancer
Verified date | September 2023 |
Source | University of Southern California |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This pilot clinical trial studies how well fluorine F 18 d-FMAU (18F-FMAU) positron emission tomography (PET)/computed tomography (CT) works in diagnosing and characterizing prostate cancer. A PET/CT scan is an imaging test that uses a small amount of radioactive tracer that is given through the vein to take detailed pictures of areas inside the body where the tracer is taken up. Radiotracers such as 18F-FMAU may help to find the cancer and see how far the disease has spread.
Status | Terminated |
Enrollment | 18 |
Est. completion date | July 21, 2021 |
Est. primary completion date | July 21, 2021 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Scheduled to undergo standard of care biopsy for suspected prostate cancer, or re-biopsy with prior negative systemic biopsy or restaging biopsy in patients with known prostate cancer on active surveillance Exclusion Criteria: - History of myocardial infarction within 6 months of the enrollment - Active infection (except mild upper respiratory infections) - Active prostatitis - Non-prostate cancers currently on treatment |
Country | Name | City | State |
---|---|---|---|
United States | USC / Norris Comprehensive Cancer Center | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
University of Southern California | National Cancer Institute (NCI), National Institute for Biomedical Imaging and Bioengineering (NIBIB) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of men for whom biopsy cores taken based only on the 18F-FMAU PET/CT results would have yielded the same overall diagnosis as the standard TRUS-guided core or the mpMRI-directed prostate biopsies | Standard descriptive methods will be used to summarize the data collected: means, standard deviations, ranges, and confidence intervals (or medians, quartiles), contingency tables, histograms, correlation coefficients (Pearson or Spearman) and scatter plots. The scatter plots and correlations between each of the histopathology parameters and the imaging parameters will be examined to better understand the relationships. | Up to 1 year | |
Primary | Proportion of men for whom the 18F-FMAU PET/CT identified all lesions that were found to have cancer based on the standard TRUS-guided and the mpMRI directed core prostate biopsies | Standard descriptive methods will be used to summarize the data collected: means, standard deviations, ranges, and confidence intervals (or medians, quartiles), contingency tables, histograms, correlation coefficients (Pearson or Spearman) and scatter plots. The scatter plots and correlations between each of the histopathology parameters and the imaging parameters will be examined to better understand the relationships. | Up to 1 year | |
Primary | Proportion of men who completed both imaging procedures and for whom biopsy cores taken based only on the fluorine 18F-FMAU PET/CT results would have yielded the same overall diagnosis as the standard TRUS-guided core prostate biopsies | Standard descriptive methods will be used to summarize the data collected: means, standard deviations, ranges, and confidence intervals (or medians, quartiles), contingency tables, histograms, correlation coefficients (Pearson or Spearman) and scatter plots. The scatter plots and correlations between each of the histopathology parameters and the imaging parameters will be examined to better understand the relationships. | Up to 1 year |
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