HypogonadismNCT06191575
7 Tesla MRI Neuroimaging in Testicular Cancer Patients With Hypogonadism and on Androgen Replacement Therapy
An observational study of Hypogonadism and Malignant Testicular Germ Cell Tumor, run by University of Southern California at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hypogonadism, Malignant Testicular Germ Cell Tumor
- What is being tested?
- 7 Tesla Magnetic Resonance Imaging, Biospecimen Collection and Cognitive Assessment
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Nov 2022to 31 Dec 2027
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
Los Angeles General Medical Center
Los Angeles, California, 90033
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: A Pilot Study of 7 Tesla MRI Neuroimaging in Testicular Cancer Patients With Hypogonadism and Androgen Replacement Therapy
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).
Read the detailed description
PRIMARY OBJECTIVE:
- 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.
- Conditions
- Hypogonadism, Malignant Testicular Germ Cell Tumor
- Being tested
- 7 Tesla Magnetic Resonance Imaging, Biospecimen Collection, Cognitive Assessment
- Medical subject headings
- Hypogonadism, Testicular Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7 Tesla Magnetic Resonance ImagingProcedure or surgery
Also called 7 T MRI, 7 Tesla MRI
Undergo 7T MRI
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood sample collection
Cognitive AssessmentProcedure or surgery
Undergo cognitive assessment
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: 7 Tesla Magnetic Resonance Imaging; Procedure: Biospecimen Collection; Procedure: Cognitive Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain structural connectivity
Measured using T1-weighted and diffusion tensor magnetic resonance imaging (MRI).
Measured: At baseline and 12 months
Brain functional connectivity
Measured using resting-state functional MRI.
Measured: At baseline and 12 months
Brain metabolic profiles
Evaluated by MR spectroscopy.
Measured: At baseline and 12 months
Brain perfusion
Evaluated by arterial spin labeling MRI.
Measured: At baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start29 Nov 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Why it stopped: Study team is conducting interim analysis.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypogonadismStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Mark S Shiroishi, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06191575
- Sponsor's protocol ID
- 4T-22-1
- Other IDs
- NCI-2022-07931, 4T-22-1, P30CA014089
- Status last verified
- Jun 2026
- First submitted
- 19 Dec 2023
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of 7 Tesla MRI Neuroimaging in Testicular Cancer Patients With Hypogonadism and Androgen Replacement Therapy
- ClinicalTrials.gov ID
- NCT06191575
- Acronym / sponsor ID
- 4T-22-1
- Conditions
- Hypogonadism, Malignant Testicular Germ Cell Tumor
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Study team is conducting interim analysis.
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 29 Nov 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (7T MRI, cognitive assessment, blood collection) | – | Procedure: 7 Tesla Magnetic Resonance Imaging, Procedure: Biospecimen Collection, Procedure: Cognitive AssessmentPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- History of any neuropsychiatric disease
- History of narcotic use or psychiatric medications
- History of ART prior to current ART regimen
- Standard contraindications for MRI:
- Current active second malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 7 Tesla Magnetic Resonance ImagingAlso: 7 T MRI, 7 Tesla MRIUndergo 7T MRI | Procedure or surgery | Observational (7T MRI, cognitive assessment, blood collection) |
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Observational (7T MRI, cognitive assessment, blood collection) |
| Cognitive AssessmentUndergo cognitive assessment | Procedure or surgery | Observational (7T MRI, cognitive assessment, blood collection) |
Primary outcome
Brain structural connectivity
Time frame: At baseline and 12 months
Measured using T1-weighted and diffusion tensor magnetic resonance imaging (MRI).
Brain functional connectivity
Time frame: At baseline and 12 months
Measured using resting-state functional MRI.
Brain metabolic profiles
Time frame: At baseline and 12 months
Evaluated by MR spectroscopy.
Brain perfusion
Time frame: At baseline and 12 months
Evaluated by arterial spin labeling MRI.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark S Shiroishi, MD principal investigator
University of Southern California
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypogonadism and Malignant Testicular Germ Cell Tumor, run by University of Southern California at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain structural connectivity (time frame: At baseline and 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.