Study on Neuroepithelial Tumor Grading and Pseudoprogression After Glioma Therapy Using Advanced Functional MRI Techniques

NCT02622620 | Unknown

• 1 other identifier: 2014JZ2-007
• Study Type: observational
• Target: 86
• Locations: 0 countries
• Sites: N/A

Brief Summary

Contrast-enhanced MRI is the most common way for evaluating neuroepithelial tumor grading and monitoring for tumor recurrence,but the ability to predict tumor behavior remains very limited.In this study, the investigators will use multi-b-value diffusion-weighted imaging(DWI),three-dimensional arterial spin labeling(3D-ASL) and dynamic contrast-enhanced MRI imaging(DCE) to evaluate neuroepithelial tumor grading and monitor for tumor recurrence.

Conditions

Glioma; Neoplasms

Keywords

dynamic contrast-enhanced MR imaging; three-dimensional arterial spin labeling; diffusion-weighted imaging

Outcome Measures

Primary Outcomes (1)

• To prospectively acquire multiparameter MR variables at 3T MRI from treated high grade glioma patients to assign tissue signatures for tumor recurrence and pseudoprogression as established by pathologic examination

  24 months

Secondary Outcomes (1)

• To compare the predictive values of the multiparameter MR tissue signatures acquired at 3T

  24 months

Study Arms (1)

Patients with glioma

Patients with high-grade glioma (glioblastoma multiforme or anaplastic astrocytoma), who receive concurrent chemoradiation (CCRT) with temozolomide

Eligibility Criteria

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

Study Population

Patients with high-grade glioma (glioblastoma multiforme or anaplastic astrocytoma), who receive concurrent chemoradiation (CCRT) with temozolomide

You may qualify if:

• Among the patients with high-grade glioma (glioblastoma multiforme or anaplastic astrocytoma), who received concurrent chemoradiation (CCRT) with temozolomide, the patients show the measurable enhancing portion (1 cm in the long diameter according to the RANO criteria) in the immediate f/up MRI after CCRT.

You may not qualify if:

• Among the patients with high-grade glioma (glioblastoma multiforme or anaplastic astrocytoma), who received concurrent chemoradiation (CCRT) with temozolomide, the patients do not show the measurable enhancing portion (1 cm in the long diameter according to the RANO criteria) in the immediate f/up MRI after CCRT.

Sponsors & Collaborators

• Tang-Du Hospital: lead

Related Publications (2)

• Yan LF, Sun YZ, Zhao SS, Hu YC, Han Y, Li G, Zhang X, Tian Q, Liu ZC, Yang Y, Nan HY, Yu Y, Sun Q, Zhang J, Chen P, Hu B, Li F, Han TH, Wang W, Cui GB. Perfusion, Diffusion, Or Brain Tumor Barrier Integrity: Which Represents The Glioma Features Best? Cancer Manag Res. 2019 Nov 27;11:9989-10000. doi: 10.2147/CMAR.S197839. eCollection 2019.

  PMID: 31819632 DERIVED

• Liu ZC, Yan LF, Hu YC, Sun YZ, Tian Q, Nan HY, Yu Y, Sun Q, Wang W, Cui GB. Combination of IVIM-DWI and 3D-ASL for differentiating true progression from pseudoprogression of Glioblastoma multiforme after concurrent chemoradiotherapy: study protocol of a prospective diagnostic trial. BMC Med Imaging. 2017 Feb 1;17(1):10. doi: 10.1186/s12880-017-0183-y.

  PMID: 28143434 DERIVED

MeSH Terms

Conditions

Glioma; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Design

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

Study Record Dates

• First Submitted: November 18, 2015
• First Posted: December 4, 2015
• Study Start: July 1, 2016
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: March 29, 2016

Record last verified: 2016-03