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Noninvasively Predicting Gene Status of Glioma (NPGSOG)

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ClinicalTrials.gov Identifier: NCT03102112
Recruitment Status : Enrolling by invitation
First Posted : April 5, 2017
Last Update Posted : April 5, 2017
Sponsor:
Information provided by (Responsible Party):
Tang-Du Hospital

Brief Summary:
Malignant gliomas are the most common and deadly primary brain tumors in adults. The clinical outcome of patients with glioblastoma depends on key molecular genetic alteration. Specifically, Isocitrate Dehydrogenase Gene Mutation, an independent favorable prognostic factor, serve as diagnostic and prognostic markers of glioma. Thus, accurate grading of a glioma is fundamental in order to determine the treatment strategy. Amide proton transfer (APT) imaging is a noninvasive molecular MRI technique based on chemical exchange saturation transfer mechanism that detects endogenous mobile proteins and peptides in biological tissues. Preliminary studies have shown that APT-weighted (APTw) signal intensity could serve as a new imaging biomarker, by revealing significantly higher signal intensities in the high-grade gliomas compared with the low-grade gliomas. The purpose of this study was to investigate the value of amide proton transfer imaging (APT) in the noninvasive evaluation of isocitrate dehydrogenase (IDH) gene status in glioma.

Condition or disease Intervention/treatment
Glioma of Brain Other: MRI examination

Detailed Description:

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.

Statistical analysis:

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
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Inpatients and out patients with head MRI scans and symptoms that suggested a cerebral mass.
Criteria

Inclusion Criteria:

  • no hypertension or cerebral vascular diseases
  • no use of corticosteroid drugs
  • no MRI contraindication
  • no allergic constitution

Exclusion Criteria:

  • pregnant wowan
  • motion cause poor image quality

Information from the National Library of Medicine

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


Locations
China, Shanxi
Yu han
Xi'an, Shanxi, China, 710038
Sponsors and Collaborators
Tang-Du Hospital
Investigators
Principal Investigator: Yu Han, MD Department of Radiology, Tangdu Hospital, the Fourth Military Medical University

Responsible Party: Tang-Du Hospital
ClinicalTrials.gov Identifier: NCT03102112     History of Changes
Other Study ID Numbers: TDLL-20151013
First Posted: April 5, 2017    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tang-Du Hospital:
Glioma APT MRI

Additional relevant MeSH terms:
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue