SuspendedNot Applicable

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

Stopped: Study team is conducting interim analysis.

United States10 participantsStarted 2022-11-29

Plain-language 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).

Who can participate

Age range18 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Brain structural connectivity

Timeframe: At baseline and 12 months

Brain functional connectivity

Timeframe: At baseline and 12 months

Brain metabolic profiles

Timeframe: At baseline and 12 months

Brain perfusion

Timeframe: At baseline and 12 months

Trial details

NCT IDNCT06191575

SponsorUniversity of Southern California

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-12-31

View on ClinicalTrials.gov More Hypogonadism trials

Plain-language summary

Who can participate

Age range18 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.