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

High Grade Glioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01499823
• Other study ID #: H-1108-032-372
• Status: Enrolling by invitation
• Phase: N/A
• First received: December 19, 2011
• Last updated: December 27, 2013
• Start date: December 2011
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 74
• Est. completion date: December 2013
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Glioma
• High Grade Glioma

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Permeability Map to Distinguish Progression From Pseudoprogression in High-grade glioma		2year	No