Status:
COMPLETED
An Investigational Scan (7 Tesla MRI) in Diagnosing Cognitive Impairment in Patients With Non-Metastatic Prostate Cancer
Lead Sponsor:
University of Southern California
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Non-Metastatic Prostate Carcinoma
Stage I Prostate Cancer AJCC v8
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
This trial studies 7 Tesla magnetic resonance imaging (MRI) in diagnosing cognitive impairment in patients with prostate cancer that has not spread to other places in the body (non-metastatic) and who...
Detailed Description
PRIMARY OBJECTIVES: 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 we...
Eligibility Criteria
Inclusion
- Ability to understand and the willingness to sign a written informed consent
- Group 1 (G1): Non-metastatic biopsy-proven prostate cancer patients on current ADT and
- Group 2 (G2): Demographically (age, cancer stage) matched non-metastatic biopsy proven prostate cancer patients without a history of ADT
- Ability to undergo imaging procedure without any form of sedation
- Ability to complete brief cognitive testing on iPad
Exclusion
- History of dementia or other neuropsychiatric disease
- History of other cancer medical therapies other than ADT, narcotics or psychiatric medications
- Standard contraindications for MRI:
- Prior work as a machinist or metal worker, or history of metal being removed from the eyes,
- Cardiac pacemaker or internal pacing wires,
- Non-MRI compatible vena cava filter, vascular aneurysm clip, heart valve, spinal or ventricular shunt, optic implant, neuro-stimulator unit, ocular implant, or intrauterine device, or
- Claustrophobia, or uncontrollable motion disorder
- Currently active second malignancy
- Any significant cardiovascular conditions (New York Heart Association \[NYHA\]) class III or IV congestive heart failure, myocardial infarction within 6 months, unstable angina, pacemaker); or
- Renal disease with calculated creatinine clearance of \< 45 ml/min
Key Trial Info
Start Date :
August 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 17 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04318028
Start Date
August 11 2020
End Date
May 17 2023
Last Update
March 17 2025
Active Locations (1)
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1
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033