Monitoring Anti-angiogenic Therapy in Brain Tumors by Advanced MRI

Description

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 Start Date

August, 01 2016

Estimated Completion Date

August 2021

Interventions

  • Radiation: Temozolomide
  • Device: MRI
  • Radiation: Avastin
  • Radiation: Lomustine
  • Device: MRS
  • Device: DSC

Study ID

Massachusetts General Hospital -- 16-147

Status

Recruiting

Trial ID

NCT02843230

Study Type

Observational

Trial Phase

N/A

Enrollment Quota

85

Sponsor

Massachusetts General Hospital

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 have normal organ and marrow function as defined below:
  • leukocytes ?3,000/mcL
  • absolute neutrophil count ?1,500/mcL
  • platelets ?100,000/mcL
  • total bilirubin within normal institutional limits
  • AST(SGOT)/ALT(SGPT) ?2.5 × institutional upper limit of normal
  • 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

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (6)

Study Location Distance Name Phone Email
Massachusetts general Hospital - Boston, Massachusetts 2.8 miles EvaMaria Ratai PhD 617-726-1744 eratai@mgh.harvard.edu
Massachusetts general Hospital - Boston, Massachusetts 2.8 miles EvaMaria Ratai PhD 617-726-1744 eratai@mgh.harvard.edu
Massachusetts general Hospital - Boston, Massachusetts 2.8 miles EvaMaria Ratai PhD 617-726-1744 eratai@mgh.harvard.edu
Massachusetts general Hospital - Boston, Massachusetts 2.8 miles EvaMaria Ratai PhD 617-726-1744 eratai@mgh.harvard.edu
Massachusetts general Hospital - Boston, Massachusetts 2.8 miles EvaMaria Ratai PhD 617-726-1744 eratai@mgh.harvard.edu
Massachusetts general Hospital - Boston, Massachusetts 2.8 miles EvaMaria Ratai PhD 617-726-1744 eratai@mgh.harvard.edu

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