GlioblastomaEarly Phase 1NCT01867593
MET-PET for Newly Diagnosed Glioblastoma
A Early Phase 1 study testing C-11 methionine PET in people with Glioblastoma, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- C-11 methionine PET
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Sep 2016
- Phase
- Early Phase 1
- 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
Who may be able to join
- Histologically or cytologically confirmed newly-diagnosed glioblastoma or gliosarcoma and planning to undergo standard chemoradiation treatment
- Life expectancy of at least 12 weeks
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: 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.
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. 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.
Read the detailed description
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.
- Conditions
- Glioblastoma
- Being tested
- C-11 methionine PET
- Keywords
- Newly diagnosed
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-11 methionine PETDevice
| Study group | Role | What they receive |
|---|---|---|
| C-11 methionine PET | Experimental | C-11 methionine PET pre and post radiation Receives: Device: C-11 methionine PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of C-11 methionine PET on progression free survival
PET uptake at 1 month after chemoRT (lesion/normal ratio) correlated with progression free survival
Measured: 2 years
Secondary outcomes (3)
Evaluate for discordance in tumor volumes
The exclusion ratio (ER) is defined as the percentage of the metabolic tumor volume that is exclusively shown by MET-PETC-11 methionine PET that is excluded from the target radiation volume as defined by MRI. The persistence ratio (PR) is the percentage of residual metabolic tumor volume remaining after chemoradiation therapy and will be determined using the following equation: (volume of metabolic tumor on post-treatment scan at original site of disease)/(volume of metabolic tumor on pre-treatment MET-PETC-11 methionine PET scan).
Measured: 2 years
Compare pre-radiation and follow-up C-11 methionine PET imaging in predicting sites of failure
Volume of overlap between pretreatment PET volumes and post-treatment regions of failure.
Measured: 2 years
Compare pre-radiation and follow-up C-11 methionine PET in predicting occurrence of pseudoprogression
Volume of overlap between pretreatment PET volumes and post-treatment regions of pseudoprogression.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study startJan 2014
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin Oh, M.D., Massachusetts General Hospital
- Investigators
- Kevin Oh, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01867593
- Sponsor's protocol ID
- 13-018
- Status last verified
- Oct 2017
- First submitted
- 16 May 2013
- Last updated
- 13 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of MET-PET (L-[Methyl]-11C Methionine Positron Emission Tomography) to Evaluate for Treatment Response After Chemoradiation Therapy for Newly-diagnosed Glioblastoma
- ClinicalTrials.gov ID
- NCT01867593
- Acronym / sponsor ID
- 13-018
- Conditions
- Glioblastoma
- Keywords
- Newly diagnosed
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 4 Jun 2013 (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 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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| C-11 methionine PET | Experimental | Device: C-11 methionine PETC-11 methionine PET pre and post radiation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Histologically or cytologically confirmed newly-diagnosed glioblastoma or gliosarcoma and planning to undergo standard chemoradiation treatment
- Life expectancy of at least 12 weeks
Key exclusion criteria (13 listed)
- 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
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 |
|---|---|---|
| C-11 methionine PET | Device | C-11 methionine PET |
Primary outcome
Effect of C-11 methionine PET on progression free survival
Time frame: 2 years
PET uptake at 1 month after chemoRT (lesion/normal ratio) correlated with progression free survival
3 secondary outcomes
Evaluate for discordance in tumor volumes
Time frame: 2 years
Compare pre-radiation and follow-up C-11 methionine PET imaging in predicting sites of failure
Time frame: 2 years
Compare pre-radiation and follow-up C-11 methionine PET in predicting occurrence of pseudoprogression
Time frame: 2 years
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 13 Oct 2017.
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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.
Kevin Oh, 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 Early Phase 1 study testing C-11 methionine PET in people with 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 2 inclusion and 13 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 13 Oct 2017. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Effect of C-11 methionine PET on progression free survival (time frame: 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 13 Oct 2017.