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| ID | Type | Description | Link |
|---|---|---|---|
| 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 | View source |
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Study team is conducting interim analysis.
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 7 Tesla Magnetic Resonance Imaging | Procedure | Undergo 7T MRI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Brain structural connectivity | Measured using T1-weighted and diffusion tensor magnetic resonance imaging (MRI). | At baseline and 12 months |
| Brain functional connectivity | Measured using resting-state functional MRI. | At baseline and 12 months |
| Brain metabolic profiles | Evaluated by MR spectroscopy. | At baseline and 12 months |
| Brain perfusion | Evaluated by arterial spin labeling MRI. | At baseline and 12 months |
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Inclusion Criteria:
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:
Current active second malignancy
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Male testicular patients with hypogonadism on androgen replacement therapy recruited from University of Southern California/Kenneth Norris, Jr Comprehensive Cancer Center and Hospital.
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| Name | Affiliation | Role |
|---|---|---|
| Mark S Shiroishi, MD | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles General Medical Center | Los Angeles | California | 90033 | United States | ||
| USC / Norris Comprehensive Cancer Center |
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Blood
| Biospecimen Collection | Procedure | Undergo blood sample collection |
|
|
| Cognitive Assessment | Procedure | Undergo cognitive assessment |
|
| Los Angeles |
| California |
| 90033 |
| United States |
| ID | Term |
|---|---|
| D007006 | Hypogonadism |
| D013736 | Testicular Neoplasms |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D013733 | Testicular Diseases |
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| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D000073216 | Mental Status and Dementia Tests |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D009483 | Neuropsychological Tests |
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
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