Determining prognosis and treatment response: novel imaging modalities for Glioblastoma

Not Applicable

Recruiting

• Conditions: Glioblastoma; Cancer - Brain

• Registration Number: ACTRN12614001114639
• Lead Sponsor: Sir Charles Gairdner Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-10-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Patients with newly diagnosed, histologically confirmed glioblastoma grade IV.
Planned to undergo radiotherapy or combined chemoradiotherapy
ECOG performance status 0-2
Able to undertake PET imaging
Able to provide written informed consent

Exclusion Criteria

Pregnancy
Age < 18 yrs
Medical contraindication to PET imaging
Cognitive impairment resulting in inability to provide informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival (OS) measured from study entry date to date of death or study end date, whichever is earliest. Analysis will occur 18 months after final participant is recruited[Follow-up will be from study entry until the censorship date (when all patients have been followed for at least 18 months) or until deceased.]

Secondary Outcome Measures

Name	Time	Method
Progression-free survival (PFS) [Will be measured from study entry date until disease progression, as defined by the MacDonald criteria, or to study end date, whichever is earliest.];Time to Progression (TTP)<br>[Measured from study entry date until disease progression is determined based on the MacDonald criteria ];Diagnosis of pseudoprogression[Evidence of pseudoprogression will be assessed retrospectively, and will be based on a combination of radiological evidence on MRI scans, corticosteroid dose and Clinical status from study enrolement date until study end date. ]