An Investigational Scan (7T MRI) for the Imaging of Central Nervous System Tumors
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|ClinicalTrials.gov Identifier: NCT04539574|
Recruitment Status : Recruiting
First Posted : September 7, 2020
Last Update Posted : February 8, 2021
|Condition or disease||Intervention/treatment||Phase|
|Central Nervous System Neoplasm Glioma Metastatic Malignant Neoplasm in the Central Nervous System Metastatic Malignant Solid Neoplasm||Procedure: 7 Tesla Magnetic Resonance Imaging Other: Questionnaire Administration||Not Applicable|
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.
I. To assess the conspicuity of each imaging modality to differentiate radiation necrosis from progressive disease.
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.
Patients undergo 7T MRI over 60 minutes.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Validation of a Multi-Parametric Ultra-High Field MRI Protocol for Central Nervous System Malignancy|
|Actual Study Start Date :||September 4, 2020|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Experimental: Diagnostic (7T MRI)
Patients undergo 7T MRI over 60 minutes.
Procedure: 7 Tesla Magnetic Resonance Imaging
Undergo 7T MRI
Other: Questionnaire Administration
- Contrast-to-noise ratio (CNR) [ Time Frame: 1 year ]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.
- Conspicuity of each imaging modality to differentiate radiation necrosis from progressive disease [ Time Frame: After completion of magnetic resonance imaging (MRI) ]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.
- Functional (f)MRI paradigms [ Time Frame: After completion of MRI ]Will be summarized by the group mean and standard deviation.
- Patient satisfaction [ Time Frame: 1 year ]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.
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): NCT04539574
|Contact: Jason Johnsonfirstname.lastname@example.org|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Jason M. Johnson 713-792-8443 email@example.com|
|Principal Investigator: Jason M. Johnson|
|Principal Investigator:||Jason Johnson||M.D. Anderson Cancer Center|