Clinical trial NCT02843230: Monitoring Anti-angiogenic Therapy in Brain Tumors by Advanced MRI
Official title: Monitoring Anti-angiogenic Therapy in Brain Tumors by Advanced MRI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glioblastoma
Keywords: Brain Tumor
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2016-07-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with recurrent glioblstoma

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.

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

Primary outcomes:
measure: Progression Free Survival For Patients Receiving Advanced MRI and MRS
timeFrame: 6 months
measure: Overall Survival For Patients Receiving Advanced MRI and MRS
timeFrame: 12 months
Secondary outcomes:
measure: Progression Free Survival For Patient Receiving Dynamic Susceptibility Contrast
timeFrame: 6 months
measure: Overall Survival Rate For Patient Receiving Dynamic Susceptibility Contrast
timeFrame: 12 Months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts general Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Eva-Maria Ratai, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.