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Monitoring Anti-angiogenic Therapy in Brain Tumors by Advanced MRI

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ClinicalTrials.gov Identifier: NCT02843230
Recruitment Status : Recruiting
First Posted : July 25, 2016
Last Update Posted : April 3, 2019
Sponsor:
Information provided by (Responsible Party):
Eva Maria Ratai, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment
Glioblastoma Radiation: Avastin Radiation: Lomustine Radiation: Temozolomide Device: MRI Device: MRS Device: DSC

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.


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Study Type : Observational
Estimated Enrollment : 85 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Monitoring Anti-angiogenic Therapy in Brain Tumors by Advanced MRI
Actual Study Start Date : August 1, 2016
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

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.
Radiation: Avastin
Other Name: Bevacizumab

Device: MRI
Other Name: Magnetic Resonance Imaging

Device: MRS
Other Name: Magnetic Resonance Spectroscopy

Device: DSC
Other Name: 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.
Radiation: Avastin
Other Name: Bevacizumab

Radiation: Temozolomide
Other Name: Temodar

Device: MRI
Other Name: Magnetic Resonance Imaging

Device: MRS
Other Name: Magnetic Resonance Spectroscopy

Device: DSC
Other Name: Dynamic Susceptibility Contrast Imaging

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
Other Name: Bevacizumab

Radiation: Lomustine
Other Name: Ceenu

Device: MRI
Other Name: Magnetic Resonance Imaging

Device: MRS
Other Name: Magnetic Resonance Spectroscopy

Device: DSC
Other Name: Dynamic Susceptibility Contrast Imaging




Primary Outcome Measures :
  1. Progression Free Survival For Patients Receiving Advanced MRI and MRS [ Time Frame: 6 months ]
  2. Overall Survival For Patients Receiving Advanced MRI and MRS [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Progression Free Survival For Patient Receiving Dynamic Susceptibility Contrast [ Time Frame: 6 months ]
  2. Overall Survival Rate For Patient Receiving Dynamic Susceptibility Contrast [ Time Frame: 12 Months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with recurrent glioblstoma
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02843230


Contacts
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Contact: Eva-Maria Ratai, PhD 617-726-1744 eratai@mgh.harvard.edu

Locations
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United States, Massachusetts
Massachusetts general Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Eva-Maria Ratai, PhD    617-726-1744    eratai@mgh.harvard.edu   
Principal Investigator: Eva-Maria Ratai, PhD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Eva-Maria Ratai, PhD Massachusetts General Hospital

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Responsible Party: Eva Maria Ratai, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02843230     History of Changes
Other Study ID Numbers: 16-147
First Posted: July 25, 2016    Key Record Dates
Last Update Posted: April 3, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Eva Maria Ratai, Massachusetts General Hospital:
Brain Tumor
Additional relevant MeSH terms:
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Glioblastoma
Brain Neoplasms
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
Bevacizumab
Angiogenesis Inhibitors
Temozolomide
Lomustine
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action