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Permeability Map to Distinguish Progression From Pseudoprogression in High-Grade Glioma

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Seung Hong Choi, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01499823
First received: December 19, 2011
Last updated: April 11, 2013
Last verified: April 2013
History of Changes
  Purpose

The aim of the present study is to assess whether a new method of quantifying therapy-associated hemodynamic alterations based on DCE MR imaging may help to distinguish pseudoprogression from true progression in patients with high grade glioma, who received CCRT.


Condition
High Grade Glioma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Permeability Map As an Imaging Biomarker to Distinguish Progression From Pseudoprogression in High-Grade Glioma

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Permeability Map to Distinguish Progression From Pseudoprogression in High-grade glioma [ Time Frame: 2year ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: December 2011
Estimated Study Completion Date: August 2013
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with high-grade glioma
Patients with high-grade glioma (glioblastoma multiforme or anaplastic astrocytoma), who receive concurrent chemoradiation (CCRT) with temozolomide

Detailed Description:

Combination temozolomide and radiation significantly prolongs survival compared with radiation alone and has become standard treatment for glioblastoma multiforme (GBM). Response assessment in GBM is difficult as a result of the frequent occurrence of early imaging changes indistinguishable from tumor progression, termed pseudoprogression. The majority of patients remain clinically stable. It is often unclear whether current therapy should be maintained or second-line therapy initiated. The incidence of pseudoprogression after concurrent chemoradiation is15%to 30%. A potential mechanism of pseudoprogression is that radiation-induced vascular changes may lead to focal transient increase in gadolinium enhancement. Dynamic contrast-enhanced (DCE) MR imaging provides a noninvasive means for quantifying tumor vascular properties.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01499823

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: SeungHong Choi, MD, PhD Seoul National University Hospital(Radiology)
  More Information

No publications provided

Responsible Party: Seung Hong Choi, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01499823     History of Changes
Other Study ID Numbers: H-1108-032-372
Study First Received: December 19, 2011
Last Updated: April 11, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
Permeability Map
High-Grade Glioma

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

ClinicalTrials.gov processed this record on June 18, 2013