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

NCT06191575 | Suspended DMC

• 3 other identifiers: 4T-22-1NCI-2022-07931P30CA014089
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 2

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).

Conditions

Hypogonadism; Malignant Testicular Germ Cell Tumor

Outcome Measures

Primary Outcomes (4)

• Brain structural connectivity

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

  At baseline and 12 months

• Brain functional connectivity

  Measured using resting-state functional MRI.

  At baseline and 12 months

• Brain metabolic profiles

  Evaluated by MR spectroscopy.

  At baseline and 12 months

• Brain perfusion

  Evaluated by arterial spin labeling MRI.

  At baseline and 12 months

Study Arms (1)

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

Biospecimen Collection PROCEDURE

Undergo blood sample collection

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

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

Cognitive Assessment PROCEDURE

Undergo cognitive assessment

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

7 Tesla Magnetic Resonance Imaging PROCEDURE

Undergo 7T MRI

Also known as: 7 T MRI, 7 Tesla MRI

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

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Los Angeles County-USC Medical Center

Los Angeles, California, 90033, United States

Location

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Hypogonadism; Testicular Neoplasms

Interventions

Specimen Handling; Mental Status and Dementia Tests

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Testicular Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Mark S Shiroishi, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 5, 2024
• Study Start: November 29, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

US (2)