FET-PET for Evaluation of Response of Recurrent GBM to Avastin
Status: | Completed |
---|---|
Conditions: | Brain Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - 85 |
Updated: | 9/7/2018 |
Start Date: | February 2013 |
End Date: | August 2018 |
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.
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.
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:
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.
Exclusion Criteria:
1. Active intracranial infection or nonglial brain mass.
2. Recent large intracranial hemorrhage (<1 month; size to be determined by principal
investigator)
3. 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.
4. Patient lives too far from BWH and/or is unwilling/ unable to return for scheduled
imaging visits.
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:
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.
Exclusion Criteria:
1. Active intracranial infection or nonglial brain mass.
2. Recent large intracranial hemorrhage (<1 month; size to be determined by principal
investigator)
3. 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.
4. Patient lives too far from BWH and/or is unwilling/ unable to return for scheduled
imaging visits.
Inclusion Criteria:
- 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.
Exclusion Criteria:
1. Active intracranial infection or nonglial brain mass.
2. Recent large intracranial hemorrhage (<1 month; size to be determined by principal
investigator)
3. 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.
4. Patient lives too far from BWH and/or is unwilling/ unable to return for scheduled
imaging visits.
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