Neoplasms

All Conditions

Nervous System Diseases

Rare Diseases

Glioma

Central Nervous System Neoplasms

Nervous System Neoplasms

7 Tesla Magnetic Resonance Imaging

Questionnaire Administration

Max Wintermark

This trial investigates how well 7T MRI scan works in imaging central nervous system tumors. Diagnostic procedures, such as 7T MRI, may help find and diagnose central nervous system tumors and help measure a patient's response to earlier treatment. The goal of this trial is to learn if a new MRI system can provide better quality images than a standard MRI.

PRIMARY OBJECTIVE:

I. To estimate the contrast-to-noise ratio (CNR) for several imaging modalities in brain malignancy as compared with normal brain parenchyma separately by type of malignancy and treatment status.

SECONDARY OBJECTIVE:

I. To assess the conspicuity of each imaging modality to differentiate radiation necrosis from progressive disease.

EXPLORATORY OBJECTIVES:

I. To assess patient experience in the 7 Tesla (7T) magnetic resonance imaging (MRI) system compared to their most recent MRI examination.

II. To assess the typical significance values seen for areas of maximal brain activity associated with each functional MRI (fMRI) test.

III. To assess the geometric distortion of a radiation planning sequence on a ultra-high field (UHF) system.

OUTLINE:

Patients undergo 7T MRI over 60 minutes.

An Investigational Scan (7T MRI) for the Imaging of Central Nervous System Tumors

Validation of a Multi-Parametric Ultra-High Field MRI Protocol for Central Nervous System Malignancy

Will be summarized by the group mean and standard deviation.

Will be reported on a five-point Likert scale and compared between the 7 Tesla (7T) scan and the most recent clinical scan by using a Wilcoxon rank-sum test.

For each imaging modality, will calculate the CNR separately in the largest lesion/metastasis per patient as well as in all study lesions. The CNR for each imaging method will be determined and reported along with the corresponding 95% confidence interval. If enough follow-up images are obtained, will compare the CNR in lesions that respond to treatment to those that do not by using a Wilcoxon rank-sum test. Will compare the CNR between baseline and follow-up within patient by using a Wilcoxon signed-rank test. Also, for those lesions that initially respond, some will subsequently grow in size after the initial response. Of these, some will be considered radiation necrosis and some progressive disease. The CNR will be compared between lesions with necrosis and those that are progressive disease using a Wilcoxon rank-sum test.

The T1 sequence by MRI will be considered the gold standard, and will compare the conspicuity of each of the other methods to that of T1 sequencing by using McNemar's test. This analysis will first be performed in the largest lesion per patient, and then analyses will be repeated using all lesions.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Testicular Neoplasms

Hypogonadism

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Gonadal Disorders

Endocrine System Diseases

Endocrine Gland Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Male Urogenital Diseases

Testicular Diseases

Germ Cells Tumors

Testicular Germ Cell Tumor

All Drugs and Chemicals

Androgens

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.

Biospecimen Collection

Cognitive Assessment

Melissa Perkins

Mark S. Shiroishi, MD

Mark S Shiroishi, MD

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.

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

A Pilot Study of 7 Tesla MRI Neuroimaging in Testicular Cancer Patients With Hypogonadism and Androgen Replacement Therapy

Measured using T1-weighted and diffusion tensor magnetic resonance imaging (MRI).

Measured using resting-state functional MRI.

University of Southern California

Behaviors and Mental Disorders

Carcinoma

Prostatic Neoplasms

Cognitive Dysfunction

Prostatic Diseases

Cognition Disorders

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

Patients undergo 7 Tesla MRI over 30-90 minutes at baseline and 6-9 months.

This trial studies 7 Tesla magnetic resonance imaging (MRI) in diagnosing cognitive impairment in patients with prostate cancer that has not spread to other places in the body (non-metastatic) and who have or have not received androgen deprivation therapy (ADT). The MRI machine uses a strong magnet and radio wave to make images of the inside of the body. A stronger magnetic field allows greater signals and more detailed visualization of the structure and function of human body. Giving 7 Tesla MRI may help doctors learn if patients that receive ADT show more signs of cognitive dysfunction or brain fog compared to patients to patients that do not receive ADT.

PRIMARY OBJECTIVES:

I. Observe longitudinal changes in structural connectivity using T1-weighted and diffusion tensor MRI in men with non-metastatic prostate cancer on current ADT versus those who were not.

II. Observe longitudinal changes in brain functional connectivity using resting-state functional (rsf) MRI.

III. Observe longitudinal changes in brain metabolic profiles evaluated by MR spectroscopy (MRS).

IV. Exploratory assessment of correlation between testosterone and prostate specific antigen (PSA) levels with MRI measures and cognitive measures.

SECONDARY OBJECTIVES:

I. To assess the feasibility and acceptability of this approach using sequential 7T MRI in prostate cancer patients either receiving ADT or not.

OUTLINE:

Patients undergo 7 Tesla MRI over 30-90 minutes at baseline and at 6-9 months.

An Investigational Scan (7 Tesla MRI) in Diagnosing Cognitive Impairment in Patients With Non-Metastatic Prostate Cancer

A Pilot Study of 7 Tesla MRI Neuroimaging Biomarkers of Prostate Cancer-Related Cognitive Impairment

For the correlation of between testosterone and PSA levels with MRI measures and cognitive measures, the study will use scatter plots to explore the pattern of correlation. Spearmen's correlation will be used to test the correlation. Both groups will be combined for the correlation analysis.

Will be measured using T1-weighted and diffusion tensor magnetic resonance imaging (MRI).

Will be measured using resting-state functional MRI.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
An Investigational Scan (7T MRI) for the Imaging of Central Nervous System Tumors	NCT04539574	Central Nervous... Glioma Metastatic Mali... Metastatic Mali...	7 Tesla Magneti... Questionnaire A...	18 Years -	M.D. Anderson Cancer Center
7 Tesla MRI Neuroimaging in Testicular Cancer Patients With Hypogonadism and on Androgen Replacement Therapy	NCT06191575	Hypogonadism Malignant Testi...	7 Tesla Magneti... Biospecimen Col... Cognitive Asses...	18 Years -	University of Southern California
An Investigational Scan (7 Tesla MRI) in Diagnosing Cognitive Impairment in Patients With Non-Metastatic Prostate Cancer	NCT04318028	Non-Metastatic ... Stage I Prostat... Stage II Prosta... Stage IIA Prost... Stage IIB Prost... Stage IIC Prost... Stage III Prost... Stage IIIA Pros... Stage IIIB Pros... Stage IIIC Pros...	7 Tesla Magneti...	18 Years -	University of Southern California
7 Tesla MRI Neuroimaging in Testicular Cancer Patients With Hypogonadism and on Androgen Replacement Therapy	NCT06191575	Hypogonadism Malignant Testi...	7 Tesla Magneti... Biospecimen Col... Cognitive Asses...	18 Years -	University of Southern California
An Investigational Scan (7T MRI) for the Imaging of Central Nervous System Tumors	NCT04539574	Central Nervous... Glioma Metastatic Mali... Metastatic Mali...	7 Tesla Magneti... Questionnaire A...	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for 7 tesla magnetic resonance imaging