Clinical trial NCT06191575: 7 Tesla MRI Neuroimaging in Testicular Cancer Patients With Hypogonadism and on Androgen Replacement Therapy
Official title: A Pilot Study of 7 Tesla MRI Neuroimaging in Testicular Cancer Patients With Hypogonadism and Androgen Replacement Therapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypogonadism
Malignant Testicular Germ Cell Tumor
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-01-05
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Brain structural connectivity
timeFrame: At baseline and 12 months
measure: Brain functional connectivity
timeFrame: At baseline and 12 months
measure: Brain metabolic profiles
timeFrame: At baseline and 12 months
measure: Brain perfusion
timeFrame: At baseline and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Los Angeles County-USC Medical Center
state: California
city: Los Angeles
country: United States
facility: USC / Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: Mark S Shiroishi, MD
role: PRINCIPAL_INVESTIGATOR
References: