SUSPENDED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2022-11-29
Study Completion:2026-10-29
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:SUSPENDED

Study ID

NCT06191575

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Males age \>= 18 years
  2. * Diagnosed with germ cell tumor of the testis (seminoma or non-seminoma) and treated with radical orchiectomy
  3. * Diagnosed with hypogonadism and started androgen replacement therapy 6 months prior (+/- 2 weeks)
  4. * Ability to understand and the willingness to sign a written informed consent
  5. * Ability to undergo imaging procedure without any form of sedation
  1. * History of any neuropsychiatric disease
  2. * History of narcotic use or psychiatric medications
  3. * History of ART prior to current ART regimen
  4. * Standard contraindications for MRI:
  5. * Prior work as a machinist or metal worker, or history of metal being removed from the eyes
  6. * Cardiac pacemaker or internal pacing wires
  7. * 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
  8. * Claustrophobia, or uncontrollable motion disorder
  9. * Current active second malignancy

Contacts and Locations

Principal Investigator

Mark S Shiroishi, MD
PRINCIPAL_INVESTIGATOR
University of Southern California

Study Locations (Sites)

Los Angeles County-USC Medical Center
Los Angeles, California, 90033
United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
United States

Collaborators and Investigators

Sponsor: University of Southern California

  • Mark S Shiroishi, MD, PRINCIPAL_INVESTIGATOR, University of Southern California

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-29
Study Completion Date2026-10-29

Study Record Updates

Study Start Date2022-11-29
Study Completion Date2026-10-29

Terms related to this study

Additional Relevant MeSH Terms

  • Hypogonadism
  • Malignant Testicular Germ Cell Tumor