Clinical trial · Observational
Monitoring Anti-angiogenic Therapy in Brain Tumors by Advanced MRI
NCT02843230CI-TRIAL-00057678completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Avastin | Radiation | — | UNRESOLVED |
| DSC | Device | — | UNRESOLVED |
| Lomustine | Radiation | — | UNRESOLVED |
| MRI | Device | — | UNRESOLVED |
| MRS | Device | — | UNRESOLVED |
| Temozolomide | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Avastin Combine with MRI, DSC and MRS Scan
- description
- 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.
- interventionNames
- Radiation: Avastin
- Device: MRI
- Device: MRS
- Device: DSC
- label
- Avastin and Temozolomide Combine with DSC, MRI and MRS Scan
- description
- 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.
- interventionNames
- Radiation: Avastin
- Radiation: Temozolomide
- Device: MRI
- Device: MRS
- Device: DSC
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDEl-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. PMID 34751617