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SuspendedNCT06191575Updated Jun 5, 2026

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

An observational study in Hypogonadism and Malignant Testicular Germ Cell Tumor, sponsored by University of Southern California. Suspended at 2 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-05.

Sponsored by University of Southern California · Observational

Why this study was suspended
Study team is conducting interim analysis.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10
Ages
18 Years and older
Sex
Male
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Study 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).

Read the 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.

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Conditions studied

  • Hypogonadism
  • Malignant Testicular Germ Cell Tumor
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In context

Hypogonadism

345 studies on the registry are indexed under Hypogonadism; 43 are open to participants now.

This study's planned enrollment of 10 is below the median of 96 across 66 observational studies indexed under Hypogonadism.

Browse Hypogonadism studies →

Lead sponsor

University of Southern California is the lead sponsor of 773 studies on the registry; 135 are open to participants now.

Of its 68 completed or terminated interventional studies of FDA-regulated products, 32 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Male testicular patients with hypogonadism on androgen replacement therapy recruited from University of Southern California/Kenneth Norris, Jr Comprehensive Cancer Center and Hospital.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10 participants (estimated)
Biospecimen retention
Samples with dna

Groups and cohorts

  • Observational (7T MRI, cognitive assessment, blood collection)

    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.

    Procedure: 7 Tesla Magnetic Resonance Imaging · Procedure: Biospecimen Collection · Procedure: Cognitive Assessment

Interventions

  • Procedure7 Tesla Magnetic Resonance Imaging

    Undergo 7T MRI

    Also known as: 7 T MRI, 7 Tesla MRI

  • ProcedureBiospecimen Collection

    Undergo blood sample collection

    Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

  • ProcedureCognitive Assessment

    Undergo cognitive assessment

06

What researchers measure

Primary outcomes

  1. Brain structural connectivity

    Measured using T1-weighted and diffusion tensor magnetic resonance imaging (MRI).

    Time frame: At baseline and 12 months

  2. Brain functional connectivity

    Measured using resting-state functional MRI.

    Time frame: At baseline and 12 months

  3. Brain metabolic profiles

    Evaluated by MR spectroscopy.

    Time frame: At baseline and 12 months

  4. Brain perfusion

    Evaluated by arterial spin labeling MRI.

    Time frame: At baseline and 12 months

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Study locations

2 sites
  • Los Angeles General Medical Center
    Los Angeles, California 90033, United States
  • USC / Norris Comprehensive Cancer Center
    Los Angeles, California 90033, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06191575
Lead sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jan 5, 2024
Start date
Nov 29, 2022
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Jun 5, 2026

Study contacts

Mark S Shiroishi, MD
principal investigator · University of Southern California

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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