Monitoring Anti-angiogenic Therapy in Brain Tumors by Advanced MRI

NCT02843230 | Completed DMC

• 1 other identifier: 16-147
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glioblastoma

Keywords

Brain Tumor

Outcome Measures

Primary Outcomes (2)

• Progression Free Survival For Patients Receiving Advanced MRI and MRS

  6 months

• Overall Survival For Patients Receiving Advanced MRI and MRS

  12 months

Secondary Outcomes (2)

• Progression Free Survival For Patient Receiving Dynamic Susceptibility Contrast

  6 months

• Overall Survival Rate For Patient Receiving Dynamic Susceptibility Contrast

  12 Months

Study Arms (3)

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). * Subsequently, patients will receive their follow-up MRI exams every 8 weeks as standard of care. * Advanced imaging will be added to the patients' regular follow-up scans including MRS and DSC MRI.

Radiation: Avastin; Device: MRI; Device: MRS; Device: DSC

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). * Subsequently, patients will receive their follow-up MRI exams every 8 weeks as standard of care. * Advanced imaging will be added to the patients' regular follow-up scans including MRS and DSC MRI.

Radiation: Avastin; Radiation: Temozolomide; Device: MRI; Device: MRS; Device: DSC

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). * Subsequently, patients will receive their follow-up MRI exams every 6 weeks as standard of care. * Advanced imaging will be added to the patients' regular follow-up scans including MRS and DSC MRI.

Radiation: Avastin; Radiation: Lomustine; Device: MRI; Device: MRS; Device: DSC

Interventions

Avastin RADIATION

Also known as: Bevacizumab

Avastin Combine with MRI, DSC and MRS Scan; Avastin and Lomustine Combine with MRI, DSC, and MRS Scan; Avastin and Temozolomide Combine with DSC, MRI and MRS Scan

Lomustine RADIATION

Also known as: Ceenu

Avastin and Lomustine Combine with MRI, DSC, and MRS Scan

Temozolomide RADIATION

Also known as: Temodar

Avastin and Temozolomide Combine with DSC, MRI and MRS Scan

MRI DEVICE

Also known as: Magnetic Resonance Imaging

Avastin Combine with MRI, DSC and MRS Scan; Avastin and Lomustine Combine with MRI, DSC, and MRS Scan; Avastin and Temozolomide Combine with DSC, MRI and MRS Scan

MRS DEVICE

Also known as: Magnetic Resonance Spectroscopy

Avastin Combine with MRI, DSC and MRS Scan; Avastin and Lomustine Combine with MRI, DSC, and MRS Scan; Avastin and Temozolomide Combine with DSC, MRI and MRS Scan

DSC DEVICE

Also known as: Dynamic Susceptibility Contrast Imaging

Avastin Combine with MRI, DSC and MRS Scan; Avastin and Lomustine Combine with MRI, DSC, and MRS Scan; Avastin and Temozolomide Combine with DSC, MRI and MRS Scan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with recurrent glioblstoma

You may qualify if:

• 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.
• creatinine within normal institutional limits OR
• creatinine clearance ≥30 mL/min/1.73 m2 for participants with creatinine levels above institutional normal.
• 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.

You may not qualify if:

• 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:
• Claustrophobia
• Presence of metallic objects or implanted medical devices in body (i.e. cardiac pacemaker, aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants)
• Sickle cell disease
• Renal failure
• Reduced renal function, as determined by creatinine clearance \< 30 mL/min based on a serum creatinine level obtained within 28 days prior to registration

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts general Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• 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.

  PMID: 34751617 DERIVED

MeSH Terms

Conditions

Glioblastoma; Brain Neoplasms

Interventions

Bevacizumab; Lomustine; Temozolomide; Magnetic Resonance Imaging; Magnetic Resonance Spectroscopy; Perfusion Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Nitrosourea Compounds; Urea; Amides; Organic Chemicals; Nitroso Compounds; Dacarbazine; Triazenes; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Eva-Maria Ratai, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: July 21, 2016
• First Posted: July 25, 2016
• Study Start: August 1, 2016
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: April 8, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)