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Monitoring Anti-angiogenic Therapy in Brain Tumors by Advanced MRI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date July 21, 2016
First Posted Date July 25, 2016
Last Update Posted Date April 3, 2019
Actual Study Start Date August 1, 2016
Estimated Primary Completion Date August 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 22, 2016)
  • Progression Free Survival For Patients Receiving Advanced MRI and MRS [ Time Frame: 6 months ]
  • Overall Survival For Patients Receiving Advanced MRI and MRS [ Time Frame: 12 months ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02843230 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: July 22, 2016)
  • Progression Free Survival For Patient Receiving Dynamic Susceptibility Contrast [ Time Frame: 6 months ]
  • Overall Survival Rate For Patient Receiving Dynamic Susceptibility Contrast [ Time Frame: 12 Months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Monitoring Anti-angiogenic Therapy in Brain Tumors by Advanced MRI
Official Title Monitoring Anti-angiogenic Therapy in Brain Tumors by Advanced MRI
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with recurrent glioblstoma
Condition Glioblastoma
Intervention
  • Radiation: Avastin
    Other Name: Bevacizumab
  • Radiation: Lomustine
    Other Name: Ceenu
  • 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
Study Groups/Cohorts
  • 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.
    Interventions:
    • 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.
    Interventions:
    • 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.
    Interventions:
    • Radiation: Avastin
    • Radiation: Lomustine
    • Device: MRI
    • Device: MRS
    • Device: DSC
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 22, 2016)
85
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 31, 2021
Estimated Primary Completion Date August 31, 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Eva-Maria Ratai, PhD 617-726-1744 eratai@mgh.harvard.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02843230
Other Study ID Numbers 16-147
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Eva Maria Ratai, Massachusetts General Hospital
Study Sponsor Massachusetts General Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Eva-Maria Ratai, PhD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date April 2019