An Investigational Scan (7 Tesla MRI) in Diagnosing Cognitive Impairment in Patients With Non-Metastatic Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT04318028|
Recruitment Status : Recruiting
First Posted : March 23, 2020
Last Update Posted : April 5, 2021
|Condition or disease||Intervention/treatment||Phase|
|Non-Metastatic Prostate Carcinoma Stage I Prostate Cancer AJCC v8 Stage II Prostate Cancer AJCC v8 Stage IIA Prostate Cancer AJCC v8 Stage IIB Prostate Cancer AJCC v8 Stage IIC Prostate Cancer AJCC v8 Stage III Prostate Cancer AJCC v8 Stage IIIA Prostate Cancer AJCC v8 Stage IIIB Prostate Cancer AJCC v8 Stage IIIC Prostate Cancer AJCC v8||Radiation: 7 Tesla Magnetic Resonance Imaging||Not Applicable|
I. Observe longitudinal changes in structural connectivity using T1-weighted and diffusion tensor MRI in men with non-metastatic prostate cancer on current ADT versus those who were not.
II. Observe longitudinal changes in brain functional connectivity using resting-state functional (rsf) MRI.
III. Observe longitudinal changes in brain metabolic profiles evaluated by MR spectroscopy (MRS).
IV. Exploratory assessment of correlation between testosterone and prostate specific antigen (PSA) levels with MRI measures and cognitive measures.
I. To assess the feasibility and acceptability of this approach using sequential 7T MRI in prostate cancer patients either receiving ADT or not.
Patients undergo 7 Tesla MRI over 30-90 minutes at baseline and at 6-9 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of 7 Tesla MRI Neuroimaging Biomarkers of Prostate Cancer-Related Cognitive Impairment|
|Actual Study Start Date :||August 11, 2020|
|Estimated Primary Completion Date :||August 11, 2022|
|Estimated Study Completion Date :||August 11, 2023|
Experimental: Diagnostic (7 Tesla MRI)
Patients undergo 7 Tesla MRI over 30-90 minutes at baseline and 6-9 months.
Radiation: 7 Tesla Magnetic Resonance Imaging
Undergo 7 Tesla MRI
- Brain structural connectivity [ Time Frame: Up to 1 year ]Will be measured using T1-weighted and diffusion tensor magnetic resonance imaging (MRI).
- Brain functional connectivity [ Time Frame: Up to 1 year ]Will be measured using resting-state functional MRI.
- Brain metabolic profiles [ Time Frame: Up to 1 year ]Will be evaluated by MR spectroscopy.
- Assessment of testosterone and prostate specific antigen (PSA) levels [ Time Frame: Up to 1 year ]For the correlation of between testosterone and PSA levels with MRI measures and cognitive measures, the study will use scatter plots to explore the pattern of correlation. Spearmen's correlation will be used to test the correlation. Both groups will be combined for the correlation analysis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04318028
|Contact: Bhushan Desai||323-442-7469||Bhushan.Desai@med.usc.edu|
|United States, California|
|USC / Norris Comprehensive Cancer Center||Recruiting|
|Los Angeles, California, United States, 90033|
|Contact: Mark S. Shiroishi 323-226-7425 Mark.Shiroishi@med.usc.edu|
|Principal Investigator: Mark S. Shiroishi|
|Principal Investigator:||Mark S Shiroishi, MD||University of Southern California|