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

University of Southern California

Status: Suspended

Conditions: Malignant Testicular Germ Cell Tumor; Hypogonadism

Treatments: Procedure: Cognitive Assessment; Procedure: Biospecimen Collection; Procedure: 7 Tesla Magnetic Resonance Imaging

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT06191575

NCI-2022-07931 (Registry Identifier)

P30CA014089 (U.S. NIH Grant/Contract)

4T-22-1 (Other Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 10 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

10 participants in 1 patient group

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

Description:

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.

Treatment:

Procedure: 7 Tesla Magnetic Resonance Imaging

Procedure: Biospecimen Collection

Procedure: Cognitive Assessment