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

A Pilot Study of 7 Tesla MRI Neuroimaging in Testicular Cancer Patients With Hypogonadism and Androgen Replacement Therapy

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).

Study Overview

• Status: Recruiting
• Conditions: Hypogonadism; Malignant Testicular Germ Cell Tumor
• Intervention / Treatment: Procedure: Biospecimen Collection; Procedure: 7 Tesla Magnetic Resonance Imaging; Procedure: Cognitive Assessment

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 Type: Observational
• Enrollment (Estimated): 10

Contacts and Locations

• Study Contact: Name: Melissa Perkins; Phone Number: 323-865-3000; Email: Melissa.Perkins@med.usc.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • Recruiting
      • USC / Norris Comprehensive Cancer Center
      • Contact: Melissa Perkins; Phone Number: 323-865-3000; Email: Melissa.Perkins@med.usc.edu
      • Principal Investigator: Mark S. Shiroishi, MD
    • Los Angeles, California, United States, 90033
      • Recruiting
      • Los Angeles County-USC Medical Center
      • Contact: Melissa Perkins; Phone Number: 323-865-3000; Email: Melissa.Perkins@med.usc.edu
      • Principal Investigator: Mark S. Shiroishi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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: Biospecimen Collection; Undergo blood sample collection; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Procedure: 7 Tesla Magnetic Resonance Imaging; Undergo 7T MRI; Other Names: 7 Tesla MRI; 7 T MRI; Procedure: Cognitive Assessment; Undergo cognitive assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Mark S Shiroishi, MD, University of Southern California

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2022
• Primary Completion (Estimated): November 29, 2025
• Study Completion (Estimated): October 29, 2026

Study Registration Dates

• First Submitted: December 19, 2023
• First Submitted That Met QC Criteria: December 19, 2023
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: December 19, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Endocrine System Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Genital Neoplasms, Male; Testicular Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Neoplasms, Germ Cell and Embryonal; Testicular Neoplasms; Hypogonadism
• Other Study ID Numbers: 4T-22-1 (Other Identifier: USC / Norris Comprehensive Cancer Center); P30CA014089 (U.S. NIH Grant/Contract); NCI-2022-07931 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No