Glioblastoma MultiformePhase 2NCT01756352
FET-PET for Evaluation of Response of Recurrent GBM to Avastin
A Phase 2 study testing 18F-FET in people with Glioblastoma Multiforme and GBM, run by Marcelo F. Di Carli, MD, FACC at 1 site in United States.
Trial summary
Hypothesis: The central hypothesis underlying the proposed research study is that FET-PET will predict durable benefit in patients receiving anti-angiogenic benefit for presumed recurrent GBM (i.e. progression-free survival and overall survival). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Glioblastoma Multiforme, GBM
- What is being tested?
- 18F-FET
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to 13 Sep 2015
- Phase
- Phase 2
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. GBM patients with changes on MRI suggestive of recurrence who have not yet initiated antiangiogenic therapy. 2. Age ≥ 18 3. Anticipated survival >3 months 4. Able to give informed consent 5. Capable of undergoing scan without the need for sedation or general anesthesia.
Who cannot join
- Active intracranial infection or nonglial brain mass.
- Recent large intracranial hemorrhage (<1 month; size to be determined by principal investigator)
- Pregnant or nursing. Quantitative serum hCG testing will be performed prior to the initial and each -subsequent FET- PET scan on all females of childbearing potential. Our BWH Radiation Safety Committee and Partners IRB requires stat serum ß-hcG pregnancy tests.
- Patient lives too far from BWH and/or is unwilling/ unable to return for scheduled imaging visits.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Assessment of the Utility of the Radiotracer "FET"in PET Imaging of Recurrent Glioblastoma Multiforme (GBM): Monitoring Early Response to Antiangiogenic Therapy
Hypothesis: The central hypothesis underlying the proposed research study is that FET-PET will predict durable benefit in patients receiving anti-angiogenic benefit for presumed recurrent GBM (i.e. progression-free survival and overall survival). We have defined one primary specific aim, for which we expect to obtain definitive results, and two secondary aims, under which we plan to generate preliminary data to support a future, larger project.
Read the detailed description
The PET radiotracer FET provides a measure of large, neutral amino acid transport. This transport is significantly upregulated in malignant brain tumors. FET rarely gives false positive findings in the setting of inflammation seen after high dose chemotherapy or radiotherapy. FET labels low-grade as well as high-grade gliomas, in contrast to FDG, which almost exclusively labels only high-grade gliomas. FET imaging may prove to be particularly useful in the setting of infiltrative tumor, which is not contrast-enhancing on MRI and therefore not detectable with FDG. Management of glioblastoma patients with stable contrast-enhancing disease on MRI but increased signs of edema is difficult. This is because it is difficult to distinguish simple edema from infiltrative tumor. The former is managed with steroids and the latter is managed with chemotherapy, and anti-angiogenic drugs.
FET may be particularly useful in assessing changes after GBM patients receive anti-vascular agents such as Avastin. Avastin is very commonly used in patients after failure of first-line treatment in GBM. Not only is Avastin costly, but it also can have serious side effects such as internal bleeding and gastric perforation, severe hypertension, poor wound healing, and renal toxicity. It is important to know when a patient is failing Avastin treatment so that the drug can be discontinued. Preliminary data in Europe (see figures below) suggests that FET-PET can accurately distinguish Avastin responders from non-responders.
Inclusion Criteria:
- GBM patients with changes on MRI suggestive of recurrence who have not yet initiated antiangiogenic therapy.
- Age ≥ 18
- Anticipated survival >3 months
- Able to give informed consent
- Capable of undergoing scan without the need for sedation or general anesthesia.
Exclusion Criteria:
- Active intracranial infection or nonglial brain mass.
- Recent large intracranial hemorrhage (<1 month; size to be determined by principal investigator)
- Pregnant or nursing. Quantitative serum hCG testing will be performed prior to the initial and each -subsequent FET- PET scan on all females of childbearing potential. Our BWH Radiation Safety Committee and Partners IRB requires stat serum ß-hcG pregnancy tests.
- Patient lives too far from BWH and/or is unwilling/ unable to return for scheduled imaging visits.
- Conditions
- Glioblastoma Multiforme, GBM
- Being tested
- 18F-FET
- Keywords
- FET, Fluoroethyl tyrosine, GBM, Response to treatment, Avastin, 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.
18F-FETDrug
Also called 18F-Fluoroethyltyrosine
Radiotracer, surrogate marker for protein synthesis
| Study group | Role | What they receive |
|---|---|---|
| GBM Avastin receiving 18F-FET | Experimental | Recurrent GBM patients receiving Avastin, imaged twice with 18F-FET PET before and approximately 8 weeks after receiving Avastin Receives: Drug: 18F-FET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival
The primary objective is to assess the utility of FET-PET imaging for prediction of progression-free survival in recurrent glioblastoma.
Measured: From date of baseline PET scan until the date of death from any cause, assessed up to 2 years.
Secondary outcomes (1)
Overall Survival
The secondary objective is to assess the utility of FET-PET imaging for prediction of overall survival in recurrent glioblastoma.
Measured: From date of baseline PET scan until the date of death from any cause, assessed up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2012 (estimated)
- Study startFeb 2013
- Primary completion13 Sep 2015
- Study completion13 Sep 2015
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 Glioblastoma MultiformeStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marcelo F. Di Carli, MD, FACC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marcelo F. Di Carli, MD, FACC, Brigham and Women's Hospital
- Investigators
- Raymond L Huang, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01756352
- Sponsor's protocol ID
- 2012P002678
- Status last verified
- Oct 2019
- First submitted
- 20 Dec 2012
- Last updated
- 30 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Utility of the Radiotracer "FET"in PET Imaging of Recurrent Glioblastoma Multiforme (GBM): Monitoring Early Response to Antiangiogenic Therapy
- ClinicalTrials.gov ID
- NCT01756352
- Acronym / sponsor ID
- 2012P002678
- Conditions
- Glioblastoma Multiforme, GBM
- Keywords
- FET, Fluoroethyl tyrosine, GBM, Response to treatment, Avastin, Brain Tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Marcelo F. Di Carli, MD, FACCUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- 13 Sep 2015 (actual)
- Study completion
- 13 Sep 2015 (actual)
- First posted
- 25 Dec 2012 (estimated)
- Results
- Posted 30 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypothesis: The central hypothesis underlying the proposed research study is that FET-PET will predict durable benefit in patients receiving anti-angiogenic benefit for presumed recurrent GBM (i.e. progression-free survival and overall survival). We have defined one primary specific aim, for which we expect to obtain definitive results, and two secondary aims, under which we plan to generate preliminary data to support a future, larger project.
Detailed description
The PET radiotracer FET provides a measure of large, neutral amino acid transport. This transport is significantly upregulated in malignant brain tumors. FET rarely gives false positive findings in the setting of inflammation seen after high dose chemotherapy or radiotherapy. FET labels low-grade as well as high-grade gliomas, in contrast to FDG, which almost exclusively labels only high-grade gliomas. FET imaging may prove to be particularly useful in the setting of infiltrative tumor, which is not contrast-enhancing on MRI and therefore not detectable with FDG. Management of glioblastoma patients with stable contrast-enhancing disease on MRI but increased signs of edema is difficult. This is because it is difficult to distinguish simple edema from infiltrative tumor. The former is managed with steroids and the latter is managed with chemotherapy, and anti-angiogenic drugs.
FET may be particularly useful in assessing changes after GBM patients receive anti-vascular agents such as Avastin. Avastin is very commonly used in patients after failure of first-line treatment in GBM. Not only is Avastin costly, but it also can have serious side effects such as internal bleeding and gastric perforation, severe hypertension, poor wound healing, and renal toxicity. It is important to know when a patient is failing Avastin treatment so that the drug can be discontinued. Preliminary data in Europe (see figures below) suggests that FET-PET can accurately distinguish Avastin responders from non-responders.
Inclusion Criteria:
- GBM patients with changes on MRI suggestive of recurrence who have not yet initiated antiangiogenic therapy.
- Age ≥ 18
- Anticipated survival >3 months
- Able to give informed consent
- Capable of undergoing scan without the need for sedation or general anesthesia.
Exclusion Criteria:
- Active intracranial infection or nonglial brain mass.
- Recent large intracranial hemorrhage (<1 month; size to be determined by principal investigator)
- Pregnant or nursing. Quantitative serum hCG testing will be performed prior to the initial and each -subsequent FET- PET scan on all females of childbearing potential. Our BWH Radiation Safety Committee and Partners IRB requires stat serum ß-hcG pregnancy tests.
- Patient lives too far from BWH and/or is unwilling/ unable to return for scheduled imaging visits.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GBM Avastin receiving 18F-FET | Experimental | Drug: 18F-FETRecurrent GBM patients receiving Avastin, imaged twice with 18F-FET PET before and approximately 8 weeks after receiving Avastin |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. GBM patients with changes on MRI suggestive of recurrence who have not yet initiated antiangiogenic therapy. 2. Age ≥ 18 3. Anticipated survival >3 months 4. Able to give informed consent 5. Capable of undergoing scan without the need for sedation or general anesthesia.
Key exclusion criteria (5 listed)
- Active intracranial infection or nonglial brain mass.
- Recent large intracranial hemorrhage (<1 month; size to be determined by principal investigator)
- Pregnant or nursing. Quantitative serum hCG testing will be performed prior to the initial and each -subsequent FET- PET scan on all females of childbearing potential. Our BWH Radiation Safety Committee and Partners IRB requires stat serum ß-hcG pregnancy tests.
- Patient lives too far from BWH and/or is unwilling/ unable to return for scheduled imaging visits.
- -
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 |
|---|---|---|
| 18F-FETAlso: 18F-FluoroethyltyrosineRadiotracer, surrogate marker for protein synthesis | Drug | GBM Avastin receiving 18F-FET |
Primary outcome
Progression-free Survival
Time frame: From date of baseline PET scan until the date of death from any cause, assessed up to 2 years.
The primary objective is to assess the utility of FET-PET imaging for prediction of progression-free survival in recurrent glioblastoma.
1 secondary outcome
Overall Survival
Time frame: From date of baseline PET scan until the date of death from any cause, assessed up to 2 years.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2019.
- 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.
Raymond L Huang, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 18F-FET in people with Glioblastoma Multiforme and GBM, run by Marcelo F. Di Carli, MD, FACC 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 1 inclusion and 5 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 Oct 2019. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Oct 2019). 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?
Progression-free Survival (time frame: From date of baseline PET scan until the date of death from any cause, assessed up to 2 years.). 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 Oct 2019.