NCT06191575

7 Tesla MRI Neuroimaging in Testicular Cancer Patients With Hypogonadism and on Androgen Replacement Therapy

A Pilot Study of 7 Tesla MRI Neuroimaging in Testicular Cancer Patients With Hypogonadism and Androgen Replacement Therapy

• Status: Suspended
• Phase: —
• Study type: Observational
• Enrollment: 10 (estimated)
• Sponsor: University of Southern California · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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 on testosterone (androgen) replacement therapy. Symptoms of hypogonadism can include fatigue, weakness, loss of libido, depression, poor concentration and erectile dysfunction. Some patients experience mental changes after diagnosis and treatment. There is some evidence that hypogonadism produces structural changes in the brain. The 7T MRI uses radio waves and a very powerful magnet linked to a computer to create detailed pictures of areas inside the body. This study may help researchers learn if 7T MRI can produce better images to assess the changes in the brain structure of testicular patients with hypogonadism and on androgen replacement therapy (ART).

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 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

• Hypogonadism
• Malignant Testicular Germ Cell Tumor

Interventions

Type	Name	Description
PROCEDURE	7 Tesla Magnetic Resonance Imaging	Undergo 7T MRI
PROCEDURE	Biospecimen Collection	Undergo blood sample collection
PROCEDURE	Cognitive Assessment	Undergo cognitive assessment

Timeline

• Start date: 2022-11-29
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2024-01-05
• Last updated: 2025-12-22

Locations

2 sites across 1 country: United States