7 Tesla MRI Neuroimaging in Testicular Cancer Patients With Hypogonadism and on Androgen Replacement Therapy
NCT ID: NCT06191575
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
10 participants
OBSERVATIONAL
2022-11-29
2027-12-31
Brief Summary
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Detailed Description
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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 is an observational study.
Patients undergo 7T MRI over 1-2 hours at baseline and at 12 months after baseline. Patients also undergo a proctored cognitive assessment over approximately 1 hour prior to each MRI. Additionally, patients undergo blood sample collection at screening and at 12 months after baseline MRI.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Observational (7T MRI, cognitive assessment, blood collection)
Patients undergo 7T MRI over 1-2 hours at baseline and at 12 months after baseline. Patients also undergo a proctored cognitive assessment over approximately 1 hour prior to each MRI. Additionally, patients undergo blood sample collection at screening and at 12 months after baseline MRI.
7 Tesla Magnetic Resonance Imaging
Undergo 7T MRI
Biospecimen Collection
Undergo blood sample collection
Cognitive Assessment
Undergo cognitive assessment
Interventions
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7 Tesla Magnetic Resonance Imaging
Undergo 7T MRI
Biospecimen Collection
Undergo blood sample collection
Cognitive Assessment
Undergo cognitive assessment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Southern California
OTHER
Responsible Party
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Principal Investigators
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Mark S Shiroishi, MD
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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Los Angeles County-USC Medical Center
Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Countries
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Other Identifiers
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NCI-2022-07931
Identifier Type: REGISTRY
Identifier Source: secondary_id
4T-22-1
Identifier Type: OTHER
Identifier Source: secondary_id
4T-22-1
Identifier Type: -
Identifier Source: org_study_id