GlioblastomaNCT02843230
Monitoring Anti-angiogenic Therapy in Brain Tumors by Advanced MRI
An observational study of Glioblastoma, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Avastin, Lomustine and Temozolomide
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2016to 31 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with recurrent glioblstoma
Who may be able to join
- 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.
Show all 11Show fewer
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts general Hospital
Boston, Massachusetts, 02114
About this study
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.
Read the 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.
- Conditions
- Glioblastoma
- Being tested
- Avastin, Lomustine, Temozolomide, MRI, MRS
- Keywords
- Brain Tumor
- Medical subject headings
- Glioblastoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvastinRadiation
Also called Bevacizumab
LomustineRadiation
Also called Ceenu
TemozolomideRadiation
Also called Temodar
MRIDevice
Also called Magnetic Resonance Imaging
MRSDevice
Also called Magnetic Resonance Spectroscopy
DSCDevice
Also called Dynamic Susceptibility Contrast Imaging
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Radiation: Avastin; Radiation: Lomustine; Device: MRI; Device: MRS; Device: DSC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival For Patients Receiving Advanced MRI and MRS
Measured: 6 months
Overall Survival For Patients Receiving Advanced MRI and MRS
Measured: 12 months
Secondary outcomes (2)
Progression Free Survival For Patient Receiving Dynamic Susceptibility Contrast
Measured: 6 months
Overall Survival Rate For Patient Receiving Dynamic Susceptibility Contrast
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2016 (estimated)
- Study start1 Aug 2016
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Maria Ratai, Massachusetts General Hospital
- Investigators
- Eva-Maria Ratai, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02843230
- Sponsor's protocol ID
- 16-147
- Status last verified
- Apr 2022
- First submitted
- 21 Jul 2016
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 34751617
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Anti-angiogenic Therapy in Brain Tumors by Advanced MRI
- ClinicalTrials.gov ID
- NCT02843230
- Acronym / sponsor ID
- 16-147
- Conditions
- Glioblastoma
- Keywords
- Brain Tumor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 25 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Avastin Combine with MRI, DSC and MRS Scan | – | Radiation: Avastin, Device: MRI, Device: MRS, Device: DSCStudy 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. |
| Avastin and Temozolomide Combine with DSC, MRI and MRS Scan | – | Radiation: Avastin, Radiation: Temozolomide, Device: MRI, Device: MRS, Device: DSCStudy 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. |
| Avastin and Lomustine Combine with MRI, DSC, and MRS Scan | – | Radiation: Avastin, Radiation: Lomustine, Device: MRI, Device: MRS, Device: DSCStudy 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with recurrent glioblstoma
Key inclusion criteria (11 listed)
- 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%)
Key exclusion criteria (10 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AvastinAlso: Bevacizumab | Radiation | Avastin Combine with MRI, DSC and MRS Scan, Avastin and Lomustine Combine with MRI, DSC, and MRS Scan, Avastin and Temozolomide Combine with DSC, MRI and MRS Scan |
| LomustineAlso: Ceenu | Radiation | Avastin and Lomustine Combine with MRI, DSC, and MRS Scan |
| TemozolomideAlso: Temodar | Radiation | Avastin and Temozolomide Combine with DSC, MRI and MRS Scan |
| MRIAlso: Magnetic Resonance Imaging | Device | Avastin Combine with MRI, DSC and MRS Scan, Avastin and Lomustine Combine with MRI, DSC, and MRS Scan, Avastin and Temozolomide Combine with DSC, MRI and MRS Scan |
| MRSAlso: Magnetic Resonance Spectroscopy | Device | Avastin Combine with MRI, DSC and MRS Scan, Avastin and Lomustine Combine with MRI, DSC, and MRS Scan, Avastin and Temozolomide Combine with DSC, MRI and MRS Scan |
| DSCAlso: Dynamic Susceptibility Contrast Imaging | Device | Avastin Combine with MRI, DSC and MRS Scan, Avastin and Lomustine Combine with MRI, DSC, and MRS Scan, Avastin and Temozolomide Combine with DSC, MRI and MRS Scan |
Primary outcome
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
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
- Derived from this study: PubMed 34751617El-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.
- Individual participant dataSharing planned: No
Related trials for Glioblastoma
Active, not recruitingPhase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Glioblastoma
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
Active, not recruitingPhase 1
Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma
Glioblastoma
RecruitingPhase 1/2
PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications
Glioma, Medulloblastoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva-Maria Ratai, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioblastoma, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival For Patients Receiving Advanced MRI and MRS (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02843230, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2022.