Response Prediction for Anti-angiogenic Treatment in Recurrent Glioblastoma

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate whether pre-treatment MRI can be used to predict treatment response for anti-angiogenic treatment in glioblastomas.

Detailed Description
-----------------
Although overall the effects on prolonging survival in bevacizumab-treated patients is modest at best, it is still unclear whether there is not a more substantial positive effect in a subset of patients, potentially identifiable by imaging markers. Allowing for prediction of good or bad responder from anti-angiogenic therapy prior to treatment completion is important to select patients most likely to benefit from anti-angiogenic treatment. This is a prospective observational study and no active comparator will be used. Study participants include adult patients with recurrent glioblastoma. We hypothesized that quantifying changes in multi-modal advanced MR imaging techniques would allow early treatment response and long-term prediction in glioblastomas.

Official Title
-----------------
Prospective Observational Study of Imaging-based Response Prediction for Anti-angiogenic Treatment in Recurrent Glioblastomas

Conditions
-----------------
Adult Glioblastoma, Magnetic Resonance Imaging, Bevacizimab

Intervention / Treatment
-----------------
* Diagnostic Test: 3-Tesla conventional magnetic resonance imaging
* Diagnostic Test: Advanced imaging without contrast use
* Diagnostic Test: Dynamic susceptibility contrast-weighted imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients had histologically confirmed glioblastoma with progression diagnosed on the basis of clinical data and MRI after standard treatment of operation, concurrent chemoradiotherapy, and adjuvant temozolomide; Patients were more than 3 months from chemoradiotherapy to avoid the confounding factor of radiation necrosis (pseudoprogression); Ability to understand and the willingness to sign a written informed consent document; all patients, or their legal guardians, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines Exclusion Criteria: Patients were not subject to therapies other than anti-angiogenic treatment, including re-operation, re-irradiation, or immunotherapies, because of the patient's clinical status and indication Patients who have any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps, etc), because such devices may be displaced or malfunction

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Received bevacizumab treatment<br>Recurrent glioblastoma patients with received anti-angiogenic treatment | Diagnostic Test: 3-Tesla conventional magnetic resonance imaging<br>* T1-weighted, T2-weighted, fluid-attenuated inversion recovery, and contrast-enhanced T1-weighted imaging<br>Diagnostic Test: Advanced imaging without contrast use<br>* Diffusion-weighted imaging, amide proton transfer-weighted imaging, electrical properties tomography, and 2hG-magnetic resonance spectroscopy<br>Diagnostic Test: Dynamic susceptibility contrast-weighted imaging<br>* Cerebral blood volume and vessel architectural imaging parameters<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival | Time from anti-angiogenic treatment until death or the first imaging report indicating worsening/progression. | Average 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-month progression | Pathologic confirmation following second look surgery or clinico-radiological assessment at 6-month | 6 month | 
| Overall survival | Time from anti-angiogenic treatment to death | Average 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Recurrent Glioblastoma; Bevacizumab; Imaging