Status:
SUSPENDED
7 Tesla MRI Neuroimaging in Testicular Cancer Patients With Hypogonadism and on Androgen Replacement Therapy
Lead Sponsor:
University of Southern California
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Hypogonadism
Malignant Testicular Germ Cell Tumor
Eligibility:
MALE
18+ years
Brief Summary
This study evaluates 7 Tesla (T) magnetic resonance imaging (MRI) in observing changes in the brain (neuroimaging) in testicular cancer patients who have decreased testosterone (hypogonadism) and are ...
Detailed Description
PRIMARY OBJECTIVE: I. To assess longitudinal structural changes in brain architecture using MRI in hypogonadal men with testis cancer being treated with androgen replacement therapy. OUTLINE: This i...
Eligibility Criteria
Inclusion
- Males age \>= 18 years
- Diagnosed with germ cell tumor of the testis (seminoma or non-seminoma) and treated with radical orchiectomy
- Diagnosed with hypogonadism and started androgen replacement therapy 6 months prior (+/- 2 weeks)
- Ability to understand and the willingness to sign a written informed consent
- Ability to undergo imaging procedure without any form of sedation
Exclusion
- History of any neuropsychiatric disease
- History of narcotic use or psychiatric medications
- History of ART prior to current ART regimen
- 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
- Current active second malignancy
Key Trial Info
Start Date :
November 29 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06191575
Start Date
November 29 2022
End Date
December 31 2027
Last Update
December 22 2025
Active Locations (2)
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1
Los Angeles County-USC Medical Center
Los Angeles, California, United States, 90033
2
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033