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

Recruiting

• Conditions: Hypogonadism; Malignant Testicular Germ Cell Tumor
• Interventions: Procedure: 7 Tesla Magnetic Resonance Imaging; Procedure: Biospecimen Collection; Procedure: Cognitive Assessment

• Registration Number: NCT06191575
• Lead Sponsor: University of Southern California

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).

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.

Study Timeline

• Study Start: 2022-11-29
• Status Verified: 2023-12
• Study First Submitted: 2023-12-19
• Study First Submitted QC: 2023-12-19
• Last Update Submitted: 2023-12-19
• Study First Posted: 2024-01-05
• Last Update Posted: 2024-01-05
• Primary Completion: 2025-11-29
• Study Completion: 2026-10-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 10

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational (7T MRI, cognitive assessment, blood collection)	Cognitive Assessment	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.
Observational (7T MRI, cognitive assessment, blood collection)	7 Tesla Magnetic Resonance Imaging	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.
Observational (7T MRI, cognitive assessment, blood collection)	Biospecimen 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.

Primary Outcome Measures

Name	Time	Method
Brain structural connectivity	At baseline and 12 months	Measured using T1-weighted and diffusion tensor magnetic resonance imaging (MRI).
Brain metabolic profiles	At baseline and 12 months	Evaluated by MR spectroscopy.
Brain perfusion	At baseline and 12 months	Evaluated by arterial spin labeling MRI.
Brain functional connectivity	At baseline and 12 months	Measured using resting-state functional MRI.

Trial Locations

Locations (2)

USC / Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States

Los Angeles County-USC Medical Center; 🇺🇸 Los Angeles, California, United States