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

Hypogonadism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06191575
• Other study ID #: 4T-22-1
• Secondary ID: NCI-2022-079314T
• Status: Recruiting
• Start date: November 29, 2022
• Est. completion date: October 29, 2026

Study information

• Verified date: December 2023
• Source: University of Southern California
• Contact: Melissa Perkins
• Phone: 323-865-3000
• Email: Melissa.Perkins[@]med.usc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: October 29, 2026
• Est. primary completion date: November 29, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypogonadism
• Malignant Testicular Germ Cell Tumor
• Neoplasms, Germ Cell and Embryonal
• Testicular Neoplasms

Intervention

Procedure:
• 7 Tesla Magnetic Resonance Imaging
Undergo 7T MRI
• Biospecimen Collection
Undergo blood sample collection
• Cognitive Assessment
Undergo cognitive assessment

Locations

Country	Name	City	State
United States	Los Angeles County-USC Medical Center	Los Angeles	California
United States	USC / Norris Comprehensive Cancer Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

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