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Brief Title: 7 Tesla MRI Neuroimaging in Testicular Cancer Patients With Hypogonadism and on Androgen Replacement Therapy
Official Title: A Pilot Study of 7 Tesla MRI Neuroimaging in Testicular Cancer Patients With Hypogonadism and Androgen Replacement Therapy
Study ID: NCT06191575
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 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Los Angeles County-USC Medical Center, Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
Name: Mark S Shiroishi, MD
Affiliation: University of Southern California
Role: PRINCIPAL_INVESTIGATOR