Using advanced MRI to study brain changes in testicular cancer patients with low testosterone
A Pilot Study of 7 Tesla MRI Neuroimaging in Testicular Cancer Patients With Hypogonadism and Androgen Replacement Therapy
University of Southern California · NCT06191575
This study is testing if advanced MRI scans can show brain changes in testicular cancer patients with low testosterone who are getting hormone therapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University of Southern California (other) |
| Locations | 2 sites (Los Angeles, California and 1 other locations) |
| Trial ID | NCT06191575 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the use of 7 Tesla magnetic resonance imaging (MRI) to observe structural changes in the brain of testicular cancer patients suffering from hypogonadism who are receiving androgen replacement therapy. Participants will undergo MRI scans at baseline and again after 12 months, alongside cognitive assessments and blood sample collection. The goal is to determine if 7T MRI can provide clearer images that reveal changes in brain architecture associated with hypogonadism and cancer treatment. This research may enhance understanding of the neurological impacts of low testosterone in this patient population.
Who should consider this trial
Good fit: Ideal candidates are males aged 18 and older diagnosed with testicular germ cell tumors and experiencing hypogonadism while on androgen replacement therapy.
Not a fit: Patients with a history of neuropsychiatric diseases or those who cannot undergo MRI due to contraindications will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic techniques for assessing brain health in testicular cancer patients undergoing hormone therapy.
How similar studies have performed: While the use of advanced MRI techniques is gaining traction, this specific application in testicular cancer patients with hypogonadism is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Los Angeles, California and 1 other locations
- Los Angeles County-USC Medical Center — Los Angeles, California, United States (RECRUITING)
- USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States (RECRUITING)
Study contacts
- Principal investigator: Mark S Shiroishi, MD — University of Southern California
- Study coordinator: Melissa Perkins
- Email: Melissa.Perkins@med.usc.edu
- Phone: 323-865-3000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hypogonadism, Malignant Testicular Germ Cell Tumor