Recurrent GlioblastomaNCT02076152
FMISO PET Study of Glioblastoma
A study testing FMISO PET, MRI and Bevacizumab in people with Recurrent Glioblastoma, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
In this research study, the investigators are using FMISO-PET and MRI scans to explore the delivery of bevacizumab to the blood vessels in patient's with recurrent glioblastoma before and after treatment. Bevacizumab is approved by the U.S. Food and Drug Administration for use in patients with recurrent glioblastoma . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Glioblastoma
- What is being tested?
- FMISO PET, MRI and Bevacizumab
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Apr 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
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. See section 10 for the evaluation of measureable disease.
- Only patients for whom their neuro-oncologist has planned to give bevacizumab as monotherapy are eligible for this study
- Age > 18 years. Because no dosing or adverse event data are currently available on the use of FMISO in participants <18 years of age, children are excluded from this study but will be eligible for future pediatric trials.
- Life expectancy of greater than 3 months.
- Karnofsky performance status > 60 (see Appendix A).
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- 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 X institutional upper limit of normal
- Creatinine within normal institutional limits or creatinine clearance > 60 mL/min/1.73 m2 for subjects with creatinine levels about institutional normal.
- Patient must be able to undergo MRI and PET scans.
- Patients must be maintained on a stable corticosteroid regimen for 5 days prior each MR-PET scan.
- The effects of FMISO on the developing human fetus are unknown. For this reason and because radiopharmaceuticals agents are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to temozolomide or FMISO.
- Participants who have already received anti-VEGF or experimental 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 FMISO is a radiopharmaceutical agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with radiopharmaceutical agents, breastfeeding should be discontinued if the mother is treated with radiopharmaceutical agents. These potential risks may also apply to other agents used in this study.
- HIV-positive individuals on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with FMISO. In addition, these individuals are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in participants receiving combination antiretroviral therapy when indicated.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 01852
About this study
Official title: A Study to Evaluate Vascular Normalization in Patients With Recurrent Glioblastoma Treated With Bevacizumab Using FMISO PET and Vascular MRI
In this research study, the investigators are using FMISO-PET and MRI scans to explore the delivery of bevacizumab to the blood vessels in patient's with recurrent glioblastoma before and after treatment.
Bevacizumab is approved by the U.S. Food and Drug Administration for use in patients with recurrent glioblastoma . It works by targeting a specific protein called VEGF, which plays a role in promoting the growth or spreading of tumor blood vessels. Since anti-VEGF agents also affect normal blood vessels in the brain, they can inhibit the way other drugs used in combination with bevacizumab are delivered to the tumor.
Read more
In PET scans, a radioactive substance is injected into the body. The scanning machine finds the radioactive substance, which tends to go to cancer cells. For the PET scans in this research study, the investigators are using an investigational radioactive substance called FMISO. "Investigational" means that the role of FMISO-PET scans is still being studied and that research doctors are trying to find out more about it. FMISO goes to areas with low oxygenation so parts of the tumor that do not have enough oxygen can be seen.
In addition, a vascular MRI will be used to evaluate the changes in tumor blood flow, blood volume, and how receptive blood vessels are. This scan will be performed at the same time of the FMISO-PET scan.
Read the detailed description
This study does not add any additional treatment to patients with malignant glioma who are already scheduled to receive bevacizumab monotherapy. All treatment decisions will be at the discretion of the treating physician. There will be no change in the diagnosis or management of the patient based on any procedures or tests carried out as a part of this study.
If the participant chooses to take part in this research study each treatment cycle will last 28 days.
- Day 1-The participant will have the following procedures done before they can receive bevacizumab:
- An assessment of the participant's tumor by Vascular MRI (Magnetic Resonance Imaging) and FMISO-PET scans
- Blood pregnancy test for women of childbearing potential.
- Day 14:The participant will have the following procedures done after they receive bevacizumab:
- An assessment of the participant's tumor by Vascular MRI (Magnetic Resonance Imaging) and FMISO-PET scans before the participant have received bevacizumab
- Blood pregnancy test for women of childbearing potential.
- Day 28: The participant will have the following procedures done after they receive bevacizumab:
- An assessment of the participant's tumor by Vascular MRI (Magnetic Resonance Imaging) and FMISO-PET scans after the participant has received bevacizumab
- Blood pregnancy test for women of childbearing potential.
FMISO-PET Scans:
- The participant will have the scans performed in Charlestown, MA at the Martinos Center. The participant will be injected with two separate intravenous (IV) injections (listed below). Intravenous means a need will be injected into a vein in the participant's arm.
- FMISO for PET scan and a contrast dye for the MRI scan
- Drawing blood to assess the radioactivity of FMISO
- The PET scan will take approximately 60-75 minutes. The participant will receive one injection of FMISO. Following the injection of the radiotracer, blood samples will be taken from the second IV line. The tracer is given through a vein (IV) and travels through the participant's blood and collects in organs and tissues. The participant will need to wait nearby as the tracer is absorbed by the their body. This takes about 90 minutes. Then, the participant will lie on a narrow table that slides into a large tunnel-shaped scanner. The PET will pick up signals from the tracer and a computer will change the signals into 3D pictures that will be displayed on a monitor for the participant's study doctor to read.
MRI Scan:
- MRI scans will last about 60-75 minutes. This will occur at the same time as the PET scan. The participant will be injected with contrast dye twice during the MRI scan. The participant will have 3 MRI scans (prior to starting treatment, day 1 of treatment and day 14 of treatment) that would not have routinely been performed if the participant were not participating in this study.
- Blood samples will be collected during both scans in order to measure how the participant blood vessels are processing the radiotracer FMISO and how well it is being delivered to the tumor tissue.
- The participant will be assessed for side effects via clinic visit or phone call about 24 hours after each of the visits above.
Planned Follow-up: The investigators would like to call the participant every 3 months for three years after the 28 day visit to see how they are doing and if the participant is experiencing any side effects. If the participant is removed from the study due to an unacceptable side effect, the participant will be followed until it has been resolved.
- Conditions
- Recurrent Glioblastoma
- Being tested
- FMISO PET, MRI, Bevacizumab, CCNU
- Keywords
- Recurrent Glioblastoma
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FMISO PETDevice
MRIDevice
MR scans will be performed with the same sequences and in the same order during each visit, including T1- and T2-weighted volumetric images, fluid attenuated inversion recovery (FLAIR), contrast agent enhanced T1-weighted permeability, diffusion tensor imaging (DTI), T2/T2*-weighted perfusion scans, and MR Spectroscopy. The "Autoalign" package available from the manufacturer will be used to achieve the same slice prescription in the same patient at each visit. Each MRI will last 60-75 minutes versus 45 minutes for standard brain MRIs.
BevacizumabDrug
Also called Avastin®
A cycle is defined as 28 days (1 month). The study duration is 12 months (12 cycles). Patients will be treated after 12 months or at the time of progression per discretion of their responsible physician.
CCNUDrug
A cycle is defined as 28 days (1 month). The study duration is 12 months (12 cycles). Patients will be treated after 12 months or at the time of progression per discretion of their responsible physician.
| Study group | Role | What they receive |
|---|---|---|
| FMISO PET & MRI Group 1 | Experimental | * Bevacizumab:
-- Bevacizumab will be administered at a dose of 10 mg/kg i.v. every 14 days per standard of care and the drug label. A cycle is defined as 28 days (1 month).
* FMISO PET Scan
* FMISO will be intravenously injected at a dose of 3.7 MBq/kg (0.1 mCi/kg) (maximum 260 MBq, 7 mCi) in < 15 mL. The IV will remain in place for injection of the gadolinium for the MRI scan. There will be one injection of FMISO in the PET protocol. Approximately 90 minutes after the injection, the PET scan will begin.
* The PET scan will be approximately 60-75 minutes.
* MRI -- Each MRI will last 60-75 minutes versus 45 minutes for standard brain MRIs. Receives: Device: FMISO PET; Device: MRI; Drug: Bevacizumab |
| FMISO PET & MRI Group 2 | Experimental | Bevacizumab + CCNU:
* Bevacizumab will be administered at a dose of 10 mg/kg i.v. every 14 days per standard of care and the drug label. A cycle is defined as 28 days (1 month).
* CCNU will be administered at a dose of 110 mg/m2 every 42 days per standard of care and the drug label. A cycle is defined as 28 days (1 month).
-FMISO PET Scan
* FMISO will be intravenously injected at a dose of 3.7 MBq/kg (0.1 mCi/kg) (maximum 260 MBq, 7 mCi) in < 15 mL. The IV will remain in place for injection of the gadolinium for the MRI scan. There will be one injection of FMISO in the PET protocol. Approximately 90 minutes after the injection, the PET scan will begin.
* The PET scan will be approximately 60-75 minutes.
- MRI
* Each MRI will last 60-75 minutes versus 45 minutes for standard brain MRIs. Receives: Device: FMISO PET; Device: MRI; Drug: Bevacizumab; Drug: CCNU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Tumor Blood Flow/Perfusion
In this research study, the investigators are using FMISO-PET and MRI scans to explore the delivery of bevacizumab to the blood vessels in patient's with recurrent glioblastoma before and after treatment.
Measured: Baseline and day 14 scans
Change in Tumor Hypoxic Volume
In this research study, the investigators are using FMISO-PET and MRI scans to explore the delivery of bevacizumab to the blood vessels in patient's with recurrent glioblastoma before and after treatment. Regional hypoxic volume (HV) was determined by thresholding the ratio of the standardized uptake values (SUV) of FMISO in the brain to cerebellum above 1.2. Since some patients had multiple tumors, we identified the HV region within the union of each contrast enhancing region of interest (ROI) and its surrounding FLAIR ROI, so individual tumors could be evaluated separately. HV represents the magnitude of hypoxia within each tumor.
Measured: Baseline and day 14 scans
Secondary outcomes (2)
Blood Vessel Permeability (Ktrans Change on MRI Scan)
The DCE-MRI data were processed using in-house custom software written in MATLAB to obtain maps of Ktrans based on the 2-parameter Tofts model. Population-level arterial input functions (AIFs) were used for DCE analysis; DCE was used only to calculate Ktrans. Median tumor values for Ktrans were calculated from the contrast enhancing region of interest (ROI). Higher value is more permeability.
Measured: Baseline and day 14
Tumor Blood Flow Measured by MRI Perfusion
This outcome measure looks at what blood flow was doing in tumor regions that were hypoxic. This outcome measured blood flow to the tumor using an MRI technique called dynamic susceptibility contrast enhancement that measures how fast injected contrast material flows through the tumor. This outcome specifically explored how blood flow to the tumor influenced tumor hypoxia.
Measured: Baseline and day 14 scans
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionApr 2019
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Recurrent 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Elizabeth R. Gerstner, MD, Massachusetts General Hospital
- Investigators
- Elizabeth Gerstner, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02076152
- Sponsor's protocol ID
- 13-482
- Other IDs
- R01CA129371
- Status last verified
- Jul 2021
- First submitted
- 6 Feb 2014
- Last updated
- 30 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate Vascular Normalization in Patients With Recurrent Glioblastoma Treated With Bevacizumab Using FMISO PET and Vascular MRI
- ClinicalTrials.gov ID
- NCT02076152
- Acronym / sponsor ID
- 13-482
- Conditions
- Recurrent Glioblastoma
- Keywords
- Recurrent Glioblastoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2014
- Primary completion
- Apr 2019 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 3 Mar 2014 (estimated)
- Results
- Posted 30 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this research study, the investigators are using FMISO-PET and MRI scans to explore the delivery of bevacizumab to the blood vessels in patient's with recurrent glioblastoma before and after treatment.
Bevacizumab is approved by the U.S. Food and Drug Administration for use in patients with recurrent glioblastoma . It works by targeting a specific protein called VEGF, which plays a role in promoting the growth or spreading of tumor blood vessels. Since anti-VEGF agents also affect normal blood vessels in the brain, they can inhibit the way other drugs used in combination with bevacizumab are delivered to the tumor.
In PET scans, a radioactive substance is injected into the body. The scanning machine finds the radioactive substance, which tends to go to cancer cells. For the PET scans in this research study, the investigators are using an investigational radioactive substance called FMISO. "Investigational" means that the role of FMISO-PET scans is still being studied and that research doctors are trying to find out more about it. FMISO goes to areas with low oxygenation so parts of the tumor that do not have enough oxygen can be seen.
In addition, a vascular MRI will be used to evaluate the changes in tumor blood flow, blood volume, and how receptive blood vessels are. This scan will be performed at the same time of the FMISO-PET scan.
Detailed description
This study does not add any additional treatment to patients with malignant glioma who are already scheduled to receive bevacizumab monotherapy. All treatment decisions will be at the discretion of the treating physician. There will be no change in the diagnosis or management of the patient based on any procedures or tests carried out as a part of this study.
If the participant chooses to take part in this research study each treatment cycle will last 28 days.
- Day 1-The participant will have the following procedures done before they can receive bevacizumab:
- An assessment of the participant's tumor by Vascular MRI (Magnetic Resonance Imaging) and FMISO-PET scans
- Blood pregnancy test for women of childbearing potential.
- Day 14:The participant will have the following procedures done after they receive bevacizumab:
- An assessment of the participant's tumor by Vascular MRI (Magnetic Resonance Imaging) and FMISO-PET scans before the participant have received bevacizumab
- Blood pregnancy test for women of childbearing potential.
- Day 28: The participant will have the following procedures done after they receive bevacizumab:
- An assessment of the participant's tumor by Vascular MRI (Magnetic Resonance Imaging) and FMISO-PET scans after the participant has received bevacizumab
- Blood pregnancy test for women of childbearing potential.
FMISO-PET Scans:
- The participant will have the scans performed in Charlestown, MA at the Martinos Center. The participant will be injected with two separate intravenous (IV) injections (listed below). Intravenous means a need will be injected into a vein in the participant's arm.
- FMISO for PET scan and a contrast dye for the MRI scan
- Drawing blood to assess the radioactivity of FMISO
- The PET scan will take approximately 60-75 minutes. The participant will receive one injection of FMISO. Following the injection of the radiotracer, blood samples will be taken from the second IV line. The tracer is given through a vein (IV) and travels through the participant's blood and collects in organs and tissues. The participant will need to wait nearby as the tracer is absorbed by the their body. This takes about 90 minutes. Then, the participant will lie on a narrow table that slides into a large tunnel-shaped scanner. The PET will pick up signals from the tracer and a computer will change the signals into 3D pictures that will be displayed on a monitor for the participant's study doctor to read.
MRI Scan:
- MRI scans will last about 60-75 minutes. This will occur at the same time as the PET scan. The participant will be injected with contrast dye twice during the MRI scan. The participant will have 3 MRI scans (prior to starting treatment, day 1 of treatment and day 14 of treatment) that would not have routinely been performed if the participant were not participating in this study.
- Blood samples will be collected during both scans in order to measure how the participant blood vessels are processing the radiotracer FMISO and how well it is being delivered to the tumor tissue.
- The participant will be assessed for side effects via clinic visit or phone call about 24 hours after each of the visits above.
Planned Follow-up: The investigators would like to call the participant every 3 months for three years after the 28 day visit to see how they are doing and if the participant is experiencing any side effects. If the participant is removed from the study due to an unacceptable side effect, the participant will be followed until it has been resolved.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FMISO PET & MRI Group 1 | Experimental | Device: FMISO PET, Device: MRI, Drug: Bevacizumab* Bevacizumab: -- Bevacizumab will be administered at a dose of 10 mg/kg i.v. every 14 days per standard of care and the drug label. A cycle is defined as 28 days (1 month). * FMISO PET Scan * FMISO will be intravenously injected at a dose of 3.7 MBq/kg (0.1 mCi/kg) (maximum 260 MBq, 7 mCi) in < 15 mL. The IV will remain in place for injection of the gadolinium for the MRI scan. There will be one injection of FMISO in the PET protocol. Approximately 90 minutes after the injection, the PET scan will begin. * The PET scan will be approximately 60-75 minutes. * MRI -- Each MRI will last 60-75 minutes versus 45 minutes for standard brain MRIs. |
| FMISO PET & MRI Group 2 | Experimental | Device: FMISO PET, Device: MRI, Drug: Bevacizumab, Drug: CCNUBevacizumab + CCNU: * Bevacizumab will be administered at a dose of 10 mg/kg i.v. every 14 days per standard of care and the drug label. A cycle is defined as 28 days (1 month). * CCNU will be administered at a dose of 110 mg/m2 every 42 days per standard of care and the drug label. A cycle is defined as 28 days (1 month). -FMISO PET Scan * FMISO will be intravenously injected at a dose of 3.7 MBq/kg (0.1 mCi/kg) (maximum 260 MBq, 7 mCi) in < 15 mL. The IV will remain in place for injection of the gadolinium for the MRI scan. There will be one injection of FMISO in the PET protocol. Approximately 90 minutes after the injection, the PET scan will begin. * The PET scan will be approximately 60-75 minutes. - MRI * Each MRI will last 60-75 minutes versus 45 minutes for standard brain MRIs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 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. See section 10 for the evaluation of measureable disease.
- Only patients for whom their neuro-oncologist has planned to give bevacizumab as monotherapy are eligible for this study
- Age > 18 years. Because no dosing or adverse event data are currently available on the use of FMISO in participants <18 years of age, children are excluded from this study but will be eligible for future pediatric trials.
- Life expectancy of greater than 3 months.
Key exclusion criteria (12 listed)
- Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to temozolomide or FMISO.
- Participants who have already received anti-VEGF or experimental 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 FMISO is a radiopharmaceutical agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with radiopharmaceutical agents, breastfeeding should be discontinued if the mother is treated with radiopharmaceutical agents. These potential risks may also apply to other agents used in this study.
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 |
|---|---|---|
| FMISO PET | Device | FMISO PET & MRI Group 1, FMISO PET & MRI Group 2 |
| MRIMR scans will be performed with the same sequences and in the same order during each visit, including T1- and T2-weighted volumetric images, fluid attenuated inversion recovery (FLAIR), contrast agent enhanced T1-weighted permeability, diffusion tensor imaging (DTI), T2/T2*-weighted perfusion scans, and MR Spectroscopy. The "Autoalign" package available from the manufacturer will be used to achieve the same slice prescription in the same patient at each visit. Each MRI will last 60-75 minutes versus 45 minutes for standard brain MRIs. | Device | FMISO PET & MRI Group 1, FMISO PET & MRI Group 2 |
| BevacizumabAlso: Avastin®A cycle is defined as 28 days (1 month). The study duration is 12 months (12 cycles). Patients will be treated after 12 months or at the time of progression per discretion of their responsible physician. | Drug | FMISO PET & MRI Group 1, FMISO PET & MRI Group 2 |
| CCNUA cycle is defined as 28 days (1 month). The study duration is 12 months (12 cycles). Patients will be treated after 12 months or at the time of progression per discretion of their responsible physician. | Drug | FMISO PET & MRI Group 2 |
Primary outcome
Change in Tumor Blood Flow/Perfusion
Time frame: Baseline and day 14 scans
In this research study, the investigators are using FMISO-PET and MRI scans to explore the delivery of bevacizumab to the blood vessels in patient's with recurrent glioblastoma before and after treatment.
Change in Tumor Hypoxic Volume
Time frame: Baseline and day 14 scans
In this research study, the investigators are using FMISO-PET and MRI scans to explore the delivery of bevacizumab to the blood vessels in patient's with recurrent glioblastoma before and after treatment. Regional hypoxic volume (HV) was determined by thresholding the ratio of the standardized uptake values (SUV) of FMISO in the brain to cerebellum above 1.2. Since some patients had multiple tumors, we identified the HV region within the union of each contrast enhancing region of interest (ROI) and its surrounding FLAIR ROI, so individual tumors could be evaluated separately. HV represents the magnitude of hypoxia within each tumor.
2 secondary outcomes
Blood Vessel Permeability (Ktrans Change on MRI Scan)
Time frame: Baseline and day 14
Tumor Blood Flow Measured by MRI Perfusion
Time frame: Baseline and day 14 scans
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Elizabeth Gerstner, MD 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?
A study testing FMISO PET, MRI and Bevacizumab in people with Recurrent 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 17 inclusion and 12 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 30 Jul 2021. 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?
Yes. Results are posted in the registry (first posted 30 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Tumor Blood Flow/Perfusion (time frame: Baseline and day 14 scans). 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?
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 30 Jul 2021.