Noninvasively Predicting Gene Status of Glioma (NPGSOG)
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|ClinicalTrials.gov Identifier: NCT03102112|
Recruitment Status : Unknown
Verified March 2017 by Tang-Du Hospital.
Recruitment status was: Enrolling by invitation
First Posted : April 5, 2017
Last Update Posted : April 5, 2017
|Condition or disease||Intervention/treatment|
|Glioma of Brain||Other: MRI examination|
Materials and Methods:
The whole brain MRI examinations were performed on a 3.0-T MRI system (Discovery MR750, General Electric Medical System, Milwaukee, WI, USA) with an eight-channel head coil (General Electric Medical System). Conventional MRI, contrast-enhanced MRI, DWI and amide proton transferimaging were performed in regular sequence during the same examination. Finally, contrast-enhanced T1-weighted spin echo sequence was acquired in the transverse, sagittal, and coronal planes after intravenous administration of 0.01 mmol/kg gadodiamide (Omniscan; GE Healthcare, Co. Cork, Ireland).
MRI data processing and image analysis:
All data were transferred to a workstation (Advantage Workstation 4.6, General Electric Medical System, Milwaukee, Wisconsin, USA) for processing.The MR imaging of all the patients were assessed independently by two experienced neuroradiologist (HYC and YLF, who have 12 and 6 years of experience, respectively, in neurologic-oncologic imaging) who were blinded to the patient's information. Next, a region of interest (ROI) was drawn manually on the solid part of the tumor with the relatively higher signal intensity on APT image.
Categorical data obtained from image were calculated using the Fisher's exact test. Quantitative data were denoted as the mean and standard deviation. The Kolmogorov-Smirnov (K-S) test was used to assess the normality of data distribution.APT-weighted (APTw) signal intensity were tested for differences between the IDH mutation and the IDH wild-type by using independent sample t test.
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Noninvasively Predicting Isocitrate Dehydrogenase Gene Status in Glioma by Amide Proton Transfer Imaging|
|Actual Study Start Date :||January 1, 2017|
|Estimated Primary Completion Date :||April 10, 2017|
|Estimated Study Completion Date :||March 3, 2018|
Patients with glioma
Consecutive patients with privious MRI scans or symptoms that suggested a cerebral mass, not yet receive treatment.
Other: MRI examination
A noninvasive medical diagnostic technique in which the absorption and transmission of high-frequency radio waves are analysed as they irradiate the hydrogen atoms in water molecules and other tissue components placed in a strong magnetic field. This computerized analysis provides a powerful aid to the diagnosis and treatment planning of many diseases, including cancer.
- APT image for assessing the gene alteration [ Time Frame: 15 months ]Prospectively acquire the APTw signal intensity to assess the efficiency for predicting the ATRX as prognostic or predictive biomarkers of gliomasloss/mutation, 1p/19q status, IDH1/2 gene mutations and MGMT promoter methylation
- APT image for predicting the survival of glioma [ Time Frame: 24 months ]to find the correlation coefficient between the APTw signal intensity and the survival of patients with glioma
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): NCT03102112
|Xi'an, Shanxi, China, 710038|
|Principal Investigator:||Yu Han, MD||Department of Radiology, Tangdu Hospital, the Fourth Military Medical University|