Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 10:44 PM
Study NCT ID:
NCT03144167
Status:
UNKNOWN
Last Update Posted:
2017-07-21
First Post:
2017-04-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Prognostic Biomarkers of Survival at 6 Months for Patients Treated With Bevacizumab Glioblastomas in First Relapse After Failure of Radiochemotherapy
Sponsor:
Centre Hospitalier Universitaire, Amiens
Organization:
Study Overview
Official Title:
Study of Prognostic Biomarkers of Survival at 6 Months for Patients Treated With Bevacizumab Glioblastomas in First Relapse After Failure of Radiochemotherapy
Status:
UNKNOWN
Status Verified Date:
2017-07
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPECTROBEVA
Brief Summary:
No predictive factors are known for the response to the bevacizumab anti-angiogenic molecule (Avastin) given in the event of relapse of glioblastoma (GBM) following radiochemotherapy. Classical MRI with gadolinium injection and perfusion is not sufficient to predict survival and response or duration. We propose to evaluate the prognostic interest for 6-month survival of spectroscopic biomarkers of proliferation, glial reaction, infiltration and glutaminergic metabolism or glycolytic metabolism recorded at 7 and 28 days of application of the treatment.
These biomarkers are based on the increase of an index combining choline / Creatine (Cho / Cr), Glx / Cr (Glutamine and glutamate / Creatine), NAA / Cr (N acetyl aspartate / Creatine) and lactate / Cr ratios. The long-term objective is to predict the survival of these relapsed GBM patients at an early stage and to identify responder patients who would benefit from this expensive molecule and avoid using it in non-responding patients
These biomarkers are based on the increase of an index combining choline / Creatine (Cho / Cr), Glx / Cr (Glutamine and glutamate / Creatine), NAA / Cr (N acetyl aspartate / Creatine) and lactate / Cr ratios. The long-term objective is to predict the survival of these relapsed GBM patients at an early stage and to identify responder patients who would benefit from this expensive molecule and avoid using it in non-responding patients
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: