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

Sponsor

Seoul National University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01499823

Collaborator

(none)

Enrollment

Location

Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
High Grade Glioma

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.

Study Design

Study Type:

Observational

Actual Enrollment :

74 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Permeability Map As an Imaging Biomarker to Distinguish Progression From Pseudoprogression in High-Grade Glioma

Study Start Date :

Dec 1, 2011

Actual Primary Completion Date :

Dec 1, 2011

Anticipated Study Completion Date :

Dec 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Permeability Map to Distinguish Progression From Pseudoprogression in High-grade glioma [2year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Seung Hong Choi, Seoul National University Hospital, Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT01499823

Other Study ID Numbers:

H-1108-032-372

First Posted:

Dec 26, 2011

Last Update Posted:

Dec 30, 2013

Last Verified:

Dec 1, 2013

Keywords provided by Seung Hong Choi, Seoul National University Hospital, Seoul National University Hospital

Permeability Map

High-Grade Glioma

Additional relevant MeSH terms:

Glioma

Study Results

No Results Posted as of Dec 30, 2013