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

NCT ID: NCT01499823

Last Updated: 2013-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

74 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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High Grade Glioma

Keywords

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Permeability Map High-Grade Glioma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with high-grade glioma

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Seung Hong Choi

Seoul National University Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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SeungHong Choi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital(Radiology)

Locations

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Seoul National University Hospital

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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H-1108-032-372

Identifier Type: -

Identifier Source: org_study_id