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Trial record 1 of 1 for:    NCT06191575
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7 Tesla MRI Neuroimaging in Testicular Cancer Patients With Hypogonadism and on Androgen Replacement Therapy

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ClinicalTrials.gov Identifier: NCT06191575
Recruitment Status : Recruiting
First Posted : January 5, 2024
Last Update Posted : January 5, 2024
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Southern California

Study Description
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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).

Condition or disease Intervention/treatment
Hypogonadism Malignant Testicular Germ Cell Tumor Procedure: 7 Tesla Magnetic Resonance Imaging Procedure: Biospecimen Collection 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 Design
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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Pilot Study of 7 Tesla MRI Neuroimaging in Testicular Cancer Patients With Hypogonadism and Androgen Replacement Therapy
Actual Study Start Date : November 29, 2022
Estimated Primary Completion Date : November 29, 2025
Estimated Study Completion Date : October 29, 2026

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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: 7 Tesla Magnetic Resonance Imaging
Undergo 7T MRI
Other Names:
  • 7 T MRI
  • 7 Tesla MRI

Procedure: Biospecimen Collection
Undergo blood sample collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection

Procedure: Cognitive Assessment
Undergo cognitive assessment


Outcome Measures
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Primary Outcome Measures :
  1. Brain structural connectivity [ Time Frame: At baseline and 12 months ]
    Measured using T1-weighted and diffusion tensor magnetic resonance imaging (MRI).

  2. Brain functional connectivity [ Time Frame: At baseline and 12 months ]
    Measured using resting-state functional MRI.

  3. Brain metabolic profiles [ Time Frame: At baseline and 12 months ]
    Evaluated by MR spectroscopy.

  4. Brain perfusion [ Time Frame: At baseline and 12 months ]
    Evaluated by arterial spin labeling MRI.


Biospecimen Retention:   Samples With DNA
Blood

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06191575


Contacts
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Contact: Melissa Perkins 323-865-3000 Melissa.Perkins@med.usc.edu

Locations
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United States, California
Los Angeles County-USC Medical Center Recruiting
Los Angeles, California, United States, 90033
Contact: Melissa Perkins    323-865-3000    Melissa.Perkins@med.usc.edu   
Principal Investigator: Mark S. Shiroishi, MD         
USC / Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Melissa Perkins    323-865-3000    Melissa.Perkins@med.usc.edu   
Principal Investigator: Mark S. Shiroishi, MD         
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Mark S Shiroishi, MD University of Southern California
More Information
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Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT06191575    
Other Study ID Numbers: 4T-22-1
NCI-2022-07931 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
4T-22-1 ( Other Identifier: USC / Norris Comprehensive Cancer Center )
P30CA014089 ( U.S. NIH Grant/Contract )
First Posted: January 5, 2024    Key Record Dates
Last Update Posted: January 5, 2024
Last Verified: December 2023

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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
Additional relevant MeSH terms:
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Neoplasms, Germ Cell and Embryonal
Testicular Neoplasms
Hypogonadism
Neoplasms by Histologic Type
Neoplasms
Gonadal Disorders
Endocrine System Diseases
Endocrine Gland Neoplasms
 Neoplasms by Site
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Male Urogenital Diseases
Testicular Diseases