Noninvasively Predicting Gene Status of Glioma

NCT03102112 | Unknown DMC

• 1 other identifier: TDLL-20151013
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioma of Brain

Keywords

Glioma APT MRI

Outcome Measures

Primary Outcomes (1)

• APT image for assessing the gene alteration

  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

  15 months

Secondary Outcomes (1)

• APT image for predicting the survival of glioma

  24 months

Study Arms (1)

Patients with glioma

Consecutive patients with privious MRI scans or symptoms that suggested a cerebral mass, not yet receive treatment.

Other: MRI examination

Interventions

MRI examination OTHER

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.

Patients with glioma

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Inpatients and out patients with head MRI scans and symptoms that suggested a cerebral mass.

You may qualify if:

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

You may not qualify if:

• pregnant wowan
• motion cause poor image quality

Sponsors & Collaborators

• Tang-Du Hospital: lead

Study Sites (1)

Yu han

Xi’an, Shanxi, 710038, China

Location

Study Officials

• Yu Han, MD

  Department of Radiology, Tangdu Hospital, the Fourth Military Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2017
• First Posted: April 5, 2017
• Study Start: January 1, 2017
• Primary Completion: April 10, 2017
• Study Completion: March 3, 2018
• Last Updated: April 5, 2017

Record last verified: 2017-03

Locations

CN (1)