Noninvasively Predicting Gene Status of Glioma (NPGSOG)

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

Study Description

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 Design

• 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

Groups and Cohorts

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.

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

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

More Information

• Responsible Party: Tang-Du Hospital
• ClinicalTrials.gov Identifier: NCT03102112
• Other Study ID Numbers: TDLL-20151013
• First Posted: April 5, 2017
• 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