NCT01499823

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
74

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

December 19, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 26, 2011

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

December 30, 2013

Status Verified

December 1, 2013

Enrollment Period

Same day

First QC Date

December 19, 2011

Last Update Submit

December 27, 2013

Conditions

High Grade Glioma

Keywords

Permeability MapHigh-Grade Glioma

Outcome Measures

Primary Outcomes (1)

  • Permeability Map to Distinguish Progression From Pseudoprogression in High-grade glioma

    2year

Study Arms (1)

Patients with high-grade glioma

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • SeungHong Choi, MD, PhD

    Seoul National University Hospital(Radiology)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Seoul National University Hospital

Study Record Dates

First Submitted

December 19, 2011

First Posted

December 26, 2011

Study Start

December 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2013

Last Updated

December 30, 2013

Record last verified: 2013-12

Locations

KR(1)