MET-PET for Newly Diagnosed Glioblastoma
| Status: | Completed |
|---|---|
| Conditions: | Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/15/2017 |
| Start Date: | January 2014 |
| End Date: | September 2016 |
Pilot Study of MET-PET (L-[Methyl]-11C Methionine Positron Emission Tomography) to Evaluate for Treatment Response After Chemoradiation Therapy for Newly-diagnosed Glioblastoma
This research study is a prospective pilot study. The purpose of a pilot clinical study is to
obtain preliminary data to support the reason for doing a larger clinical trial on testing
the clinical effectiveness of an investigational intervention. "Investigational" means that
the role of MET-PET scans is still being studied and that research doctors are trying to find
out more about it. It also means that the FDA has not approved this intervention for your
type cancer.
In this research study, the investigators are evaluating whether or not MET-PET scans have
value in predicting response to standard chemoradiation therapy in participants with
newly-diagnosed glioblastoma. A standard treatment for glioblastoma is treatment with a
combination of radiation therapy and chemotherapy with the drug temozolomide.
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. With standard PET scans, the
radioactive substance used is FDG. FDG goes to many areas of the normal brain which makes it
difficult for use in distinguishing brain tumors from normal tissue.
For the PET scans in this research study, the investigators are using a radioactive substance
called MET, instead of the standard substance FDG. MET gets absorbed by cancer cells but not
by normal brain and therefore may be better than FDG in evaluating brain tumors and therefore
may be better than FDG in evaluating brain tumors and their response to treatment.
In this research study, participants will receive standard chemotherapy and radiation therapy
for glioblastoma as well as standard MRI scans. In addition, participants will undergo
L-[Methyl]-11C Methionine Positron Emission Tomography (MET-PET) scans twice. The first
MET-PET scan will occur after enrollment but prior to radiation therapy. The second MET-PET
scan will occur approximately one month after completion of radiation therapy.
obtain preliminary data to support the reason for doing a larger clinical trial on testing
the clinical effectiveness of an investigational intervention. "Investigational" means that
the role of MET-PET scans is still being studied and that research doctors are trying to find
out more about it. It also means that the FDA has not approved this intervention for your
type cancer.
In this research study, the investigators are evaluating whether or not MET-PET scans have
value in predicting response to standard chemoradiation therapy in participants with
newly-diagnosed glioblastoma. A standard treatment for glioblastoma is treatment with a
combination of radiation therapy and chemotherapy with the drug temozolomide.
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. With standard PET scans, the
radioactive substance used is FDG. FDG goes to many areas of the normal brain which makes it
difficult for use in distinguishing brain tumors from normal tissue.
For the PET scans in this research study, the investigators are using a radioactive substance
called MET, instead of the standard substance FDG. MET gets absorbed by cancer cells but not
by normal brain and therefore may be better than FDG in evaluating brain tumors and therefore
may be better than FDG in evaluating brain tumors and their response to treatment.
In this research study, participants will receive standard chemotherapy and radiation therapy
for glioblastoma as well as standard MRI scans. In addition, participants will undergo
L-[Methyl]-11C Methionine Positron Emission Tomography (MET-PET) scans twice. The first
MET-PET scan will occur after enrollment but prior to radiation therapy. The second MET-PET
scan will occur approximately one month after completion of radiation therapy.
After agreeing to take part in this research study you will be asked to undergo some
screening tests or procedures to confirm that you are eligible. Many of these tests and
procedures are likely to be part of regular cancer care and may be done even if it turns out
that you do not take part in the research study. If you have had some of these tests or
procedure recently, they may or may not have to be repeated. The screening process will
include the following: A medical history, performance status, physical exam, routine blood
tests, assessment of your tumor, diagnosis confirmation and pregnancy test. If these tests
show that you are eligible to participate in the research study, you will begin the study
treatment. If you do not meet the eligibility criteria, you will not be able to participate
in this research study.
Within 3 weeks after your surgery you will undergo a MET-PET scan to define residual
metabolic activity.
After completion of radiation therapy at 1,3,5,7,9 and 11 months following radiation therapy
you will undergo: a medical history, physical exam, assessment of your tumor by MRI,
documentation of your current dose of steroids, blood tests and an evaluation for side
effects.
At one month after the completion of radiation therapy you will undergo the second and final
MET-PET scan to assess response to therapy.
After the 11 month follow-up visit, we would like to keep track of your medical condition for
the rest of your life as part of our routine care. If we no longer see you in person in the
clinic, we would like to do this by calling you on the telephone once a year to see how you
are doing. Keeping in touch with you and checking your condition every year helps us look at
the long-term effects of the research study.
screening tests or procedures to confirm that you are eligible. Many of these tests and
procedures are likely to be part of regular cancer care and may be done even if it turns out
that you do not take part in the research study. If you have had some of these tests or
procedure recently, they may or may not have to be repeated. The screening process will
include the following: A medical history, performance status, physical exam, routine blood
tests, assessment of your tumor, diagnosis confirmation and pregnancy test. If these tests
show that you are eligible to participate in the research study, you will begin the study
treatment. If you do not meet the eligibility criteria, you will not be able to participate
in this research study.
Within 3 weeks after your surgery you will undergo a MET-PET scan to define residual
metabolic activity.
After completion of radiation therapy at 1,3,5,7,9 and 11 months following radiation therapy
you will undergo: a medical history, physical exam, assessment of your tumor by MRI,
documentation of your current dose of steroids, blood tests and an evaluation for side
effects.
At one month after the completion of radiation therapy you will undergo the second and final
MET-PET scan to assess response to therapy.
After the 11 month follow-up visit, we would like to keep track of your medical condition for
the rest of your life as part of our routine care. If we no longer see you in person in the
clinic, we would like to do this by calling you on the telephone once a year to see how you
are doing. Keeping in touch with you and checking your condition every year helps us look at
the long-term effects of the research study.
Inclusion Criteria:
- Histologically or cytologically confirmed newly-diagnosed glioblastoma or gliosarcoma
and planning to undergo standard chemoradiation treatment
- Life expectancy of at least 12 weeks
Exclusion Criteria:
- Pregnant or breastfeeding
- Glioblastoma involving the brainstem or posterior fossa, cerebrospinal fluid
dissemination
- Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas)
- Not recovered from adverse events due to previous treatment
- Have received any treatment regimen including a VEGF-R inhibitor such as bevacizumab
or cediranib or plant to receive such agents
- Prior history of radiation therapy that would lead to overlap wtih new radiation
fields
- Prior use of radiosensitizers, Gliadel wafers or other interstitial intracranial
treatments
- Receiving any other study agent
- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to L-[methyl]-C methionine
- Prior invasive malignancy (except non-melanomatous skin cancer or disease free for at
least 3 years)
- Inability to undergo MRI with gadolinium contrast or PET imaging
- Uncontrolled intercurrent illness
- HIV positive on antiretroviral therapy
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Kevin Oh, MD
Phone: 617-724-1159
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