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This research study aims to predict treatment response to anti-angiogenic therapy (Avastin) using advanced magnetic resonance imaging (MRI) and spectroscopy (MRS) for Glioblastoma patients.
This research study is an Imaging Study, in which investigators are examining if advanced magnetic resonance imaging (MRI) and spectroscopy (MRS) are able to predict the outcome of participants with a brain tumor (glioblastoma) treated with an anti-angiogenic treatment called Avastin (Avastin is the trade name for bevacizumab).
MRI studies the tumor size and other physical aspects of a tumor and the MRS adds an additional analysis that measures the chemical changes that a tumor undergoes. This study aims to test whether addition of MRS to standard MRI testing will help better predict how a tumor is responding to therapy.
The names of the study interventions involved in this study are:
The participant's treating physician may complement the Avastin treatment with chemotherapy including Temozolomide (TMZ) or Lomustine (CCNU). Both treatments are approved by the U.S. Food and Drug Administration for use in Glioblastoma.
The purpose of this study is to predict treatment response to anti-angiogenic therapy in brain tumor participant using advanced MRI and MRS.
MRI/MRS is an FDA-approved test that uses magnets to take pictures of the brain and lets us "see inside" the body/brain without surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Avastin Combine with MRI, DSC and MRS Scan | Study subjects will have an MRI exam including MRS and DSC imaging prior to bevacizumab/ Avastin treatment (baseline scan).
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| Avastin and Temozolomide Combine with DSC, MRI and MRS Scan | Study subjects will have an MRI exam including MRS and DSC imaging prior to bevacizumab/ Avastin and Temozolomide treatment (baseline scan).
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| Avastin and Lomustine Combine with MRI, DSC, and MRS Scan | Study subjects will have an MRI exam including MRS and DSC imaging prior to bevacizumab/ Avastin and Lomustine treatment (baseline scan).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avastin | Radiation |
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| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival For Patients Receiving Advanced MRI and MRS | 6 months | |
| Overall Survival For Patients Receiving Advanced MRI and MRS | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival For Patient Receiving Dynamic Susceptibility Contrast | 6 months | |
| Overall Survival Rate For Patient Receiving Dynamic Susceptibility Contrast | 12 Months |
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Inclusion Criteria:
Participants must have histologically confirmed glioblastoma and evidence of recurrence. Patients with low-grade tumors who have progressed to glioblastoma are eligible.
Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm.
Patients must be anti-angiogenic therapy naïve.
Age ≥18 years. We exclude children because the chances of recruiting children with recurrent glioblastoma who will be treated with bevacizumab are small.
ECOG performance status ≤2 (Karnofsky ≥60%)
Life expectancy of greater than 10 weeks.
Participants must be able to undergo MRI scan.
Participants whose clinical care plan includes treatment with bevacizumab mono-therapy (Group I) or bevacizumab (+ cytotoxic agents Temozolomide (TMZ) or Lomustine (CCNU).
Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
Participants who have already received anti-VEGF or investigational anti-angiogenic therapy for glioblastoma.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Pregnant women are excluded from this study because the effects of MR imaging on the fetus are unknown and gadolinium-based intravenous contrast material is not recommended for use in pregnant patients
HIV-positive participants on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with bevacizumab, Temozolomide (TMZ) or Lomustine (CCNU).
Patients who are no suitable to undergo MRI or use gadolinium contrast due to:
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Patients with recurrent glioblstoma
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| Name | Affiliation | Role |
|---|---|---|
| Eva-Maria Ratai, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts general Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34751617 | Derived | El-Abtah ME, Wenke MR, Talati P, Fu M, Kim D, Weerasekera A, He J, Vaynrub A, Vangel M, Rapalino O, Andronesi O, Arrillaga-Romany I, Forst DA, Yen YF, Rosen B, Batchelor TT, Gonzalez RG, Dietrich J, Gerstner ER, Ratai EM. Myo-Inositol Levels Measured with MR Spectroscopy Can Help Predict Failure of Antiangiogenic Treatment in Recurrent Glioblastoma. Radiology. 2022 Feb;302(2):410-418. doi: 10.1148/radiol.2021210826. Epub 2021 Nov 9. |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D008130 | Lomustine |
| D000077204 | Temozolomide |
| D008279 | Magnetic Resonance Imaging |
| D009682 | Magnetic Resonance Spectroscopy |
| D000098642 | Perfusion Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Lomustine | Radiation |
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| Temozolomide | Radiation |
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| MRI | Device |
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| MRS | Device |
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| DSC | Device |
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| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D009607 | Nitrosourea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D009603 | Nitroso Compounds |
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |