Evaluation of 7 Tesla MRI Neuroimaging in Testicular Cancer Patients with Hypogonadism and on Androgen Replacement Therapy

Status: temporarily closed to accrual

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).

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 will be starting androgen replacement therapy or who have recently been placed on ART (< 1 month of starting ART)
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

Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06191575.

United States

California

Los Angeles

Los Angeles General Medical Center

Status: Temporarily closed to accrual

Contact: Siamak Daneshmand

Phone: 323-865-3000

Email: daneshma@med.usc.edu

USC / Norris Comprehensive Cancer Center

Status: Temporarily closed to accrual

Contact: Siamak Daneshmand

Phone: 323-865-3000

Email: daneshma@med.usc.edu

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 starting ART. 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 starting ART.

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Evaluation of 7 Tesla MRI Neuroimaging in Testicular Cancer Patients with Hypogonadism and on Androgen Replacement Therapy

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