Ignite Creation Date:
2024-05-06 @ 2:04 AM
Last Modification Date:
2024-10-26 @ 11:13 AM
Study NCT ID:
NCT01961934
Status:
WITHDRAWN
Last Update Posted:
2016-09-28
First Post:
2013-10-09
Brief Title:
C11-Sodium Acetate PETCT Imaging Evaluation in Brain Glioma Post Therapy Necrosis and Pseudo-progression
Sponsor:
Phoenix Molecular Imaging
Organization:
Phoenix Molecular Imaging
Study Overview
Official Title:
Carbon-11-Sodium Acetate Positron Emission TomographyComputed Tomography PETCT Imaging Evaluation in Brain Glioma Post Therapy Necrosis and Pseudo-progression
Status:
WITHDRAWN
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Awaiting funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will investigate how well Carbon Acetate PETCT imaging helps to correctly identify recurrent tumor versus post treatment effects radionecrosis in patients with previously treated high grade brain gliomas
Detailed Description:
The study is designed to investigate the effectiveness of Carbon Acetate PETCT AC PETin terms of its ability to distinguish between radionecrosispseudo-progression and viable tumor in patients previously treated with surgery and radiation for high grade glioma brain tumors
Eligible patients with biopsy proven high grade gliomas WHO grades 3 and 4 status-post prior cranial irradiation for this tumor age 18 to 70 ECOGZubrod of 0-2 no other contraindications to trial entry and a post-irradiation cranial MRI or CT demonstrating an enhancing lesion of uncertain etiology not biopsied will be treated with at least two weeks of steroidal therapy
Responders to steroidal therapy will be classified as either pseudo-progression if asymptomatic or radionecrosis if symptomatic Non-responders those who do not respond clinically radiographically or both will be referred for an FDG PETCT and initial AC PETCT within 3 weeks and subsequently referred for stereotactic biopsy of their lesion followed by focal laser treatment in the same operative setting within 3 weeks of AC PETCT
Specific GoalsQuestions
1 What is the yield sensitivity accuracy positive and negative predictive value of state-of-the-art PETCT with C-11 Acetate in detecting recurrent disease versus post treatment effects and pseudo-progression in this patient population
2 How does the performance of PET with C-11 Acetate compare with that of PET using F-18 fluorodeoxyglucose FDG-PET and with that of MRI
3 Evaluate the optimal timing for post injection imaging
Eligible patients with biopsy proven high grade gliomas WHO grades 3 and 4 status-post prior cranial irradiation for this tumor age 18 to 70 ECOGZubrod of 0-2 no other contraindications to trial entry and a post-irradiation cranial MRI or CT demonstrating an enhancing lesion of uncertain etiology not biopsied will be treated with at least two weeks of steroidal therapy
Responders to steroidal therapy will be classified as either pseudo-progression if asymptomatic or radionecrosis if symptomatic Non-responders those who do not respond clinically radiographically or both will be referred for an FDG PETCT and initial AC PETCT within 3 weeks and subsequently referred for stereotactic biopsy of their lesion followed by focal laser treatment in the same operative setting within 3 weeks of AC PETCT
Specific GoalsQuestions
1 What is the yield sensitivity accuracy positive and negative predictive value of state-of-the-art PETCT with C-11 Acetate in detecting recurrent disease versus post treatment effects and pseudo-progression in this patient population
2 How does the performance of PET with C-11 Acetate compare with that of PET using F-18 fluorodeoxyglucose FDG-PET and with that of MRI
3 Evaluate the optimal timing for post injection imaging
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None