Monitoring Anti-angiogenic Therapy in Brain Tumors by Advanced MRI

April 6, 2022 updated by: Eva Maria Ratai, Massachusetts General Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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:

  • MRI/MRS
  • Avastin Avastin works by interfering with the process of new blood vessel growth and is thus an anti-angiogenic. Avastin is approved by the U.S. Food and Drug Administration for use in Glioblastoma .

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.

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with recurrent glioblstoma

Description

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.

    • 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.

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:

    • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Device: MRI
Other Names:
  • Magnetic Resonance Imaging
Radiation: Avastin
Other Names:
  • Bevacizumab
Device: MRS
Other Names:
  • Magnetic Resonance Spectroscopy
Device: DSC
Other Names:
  • Dynamic Susceptibility Contrast Imaging
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.
Device: MRI
Other Names:
  • Magnetic Resonance Imaging
Radiation: Avastin
Other Names:
  • Bevacizumab
Device: MRS
Other Names:
  • Magnetic Resonance Spectroscopy
Device: DSC
Other Names:
  • Dynamic Susceptibility Contrast Imaging
Radiation: Temozolomide
Other Names:
  • Temodar
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.
Device: MRI
Other Names:
  • Magnetic Resonance Imaging
Radiation: Avastin
Other Names:
  • Bevacizumab
Device: MRS
Other Names:
  • Magnetic Resonance Spectroscopy
Device: DSC
Other Names:
  • Dynamic Susceptibility Contrast Imaging
Radiation: Lomustine
Other Names:
  • Ceenu

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression Free Survival For Patients Receiving Advanced MRI and MRS
Time Frame: 6 months
6 months
Overall Survival For Patients Receiving Advanced MRI and MRS
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression Free Survival For Patient Receiving Dynamic Susceptibility Contrast
Time Frame: 6 months
6 months
Overall Survival Rate For Patient Receiving Dynamic Susceptibility Contrast
Time Frame: 12 Months
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Eva-Maria Ratai, PhD, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Actual)

January 31, 2022

Study Completion (Actual)

January 31, 2022

Study Registration Dates

First Submitted

July 21, 2016

First Submitted That Met QC Criteria

July 22, 2016

First Posted (Estimate)

July 25, 2016

Study Record Updates

Last Update Posted (Actual)

April 8, 2022

Last Update Submitted That Met QC Criteria

April 6, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-147

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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