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 range

18 Years

Sex

MALE

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

18 Years

Sex

MALE

See this in plain English?

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