GlioblastomaNCT02367482
Tryptophan Metabolism in Human Brain Tumors-Novocure
An observational study of Glioblastoma, run by Wayne State University at 1 site in United States.
Trial summary
In this research study, we will track the build-up of tryptophan, a radioactive tracer, in the brain using positron emission tomography (PET) scanning. Tryptophan, in its natural state, is an amino acid (one of the building blocks of proteins) that is normally present in the brain, and is used by the brain cells to… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Glioblastoma
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to 31 Dec 2023
- Phase
- Observational
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients eligible and agreeable to undergo NovoTTF treatment at KCC/WSU due to recurrent glioblastoma (initial or subsequent tumor recurrence) will be recruited by the multidisciplinary neuro-oncology team to undergo the two AMT-PET studies.
Who may be able to join
- Clinical and MRI diagnosis of recurrent GBM.
- Age ≥22 years.
- Patient agrees to NovoTTF treatment but has not started treatment yet.
- Patient agrees to undergo a baseline and a follow-up AMT-PET scan during NovoTTF treatment.
- Patient able to provide informed consent.
Who cannot join
- Resective surgery within 2 months prior to the initial AMT-PET scan (acute/subacute post-surgical inflammatory changes may cause false positive increased uptake on AMT-PET).
- Severe increased intracranial pressure, status epilepticus, or other severe complications of the tumor, requiring emergency or urgent intervention.
- Positive pregnancy test (because of radiation involved in PET scanning).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tryptophan Metabolism in Human Brain Tumors: For Patients Whose Clinical Treatment Includes NovoTTF
In this research study, we will track the build-up of tryptophan, a radioactive tracer, in the brain using positron emission tomography (PET) scanning. Tryptophan, in its natural state, is an amino acid (one of the building blocks of proteins) that is normally present in the brain, and is used by the brain cells to create various other compounds. This process is altered in the presence of a brain tumor. By using a form of tryptophan marked with a small amount of radiation, we will be able to track this process during the course of the PET scan. This research will help determine if AMT PET is a useful method to recognize and differentiate between various types of brain tumors. In addition, to study the mechanisms of altered tryptophan uptake in the tumor and brain, we will also measure tryptophan levels and related molecules in your blood (obtained as a part of the PET procedure) and tumor tissue (in case you will have surgery to remove the tumor). This will help us to find new approaches to treat brain tumors in the future by altering abnormal tryptophan metabolism.
Read the detailed description
If you agree to take part in this research study, you will be asked to have:
- A PET scan, 2. brief clinical questionnaires, and 3. biochemical studies of blood and tumor tissue. You will also have a second PET scan later, 2-3 months after the start of NovoTTF therapy, to determine if there are changes in the tumor that can be detected by PET. Your ability to participate in the study will be based, in part, on the results of the magnetic resonance images (MRI) in your medical chart from earlier clinical procedures. Once we receive the results of the PET scan, these will be compared to the MRI in order to help us analyze the tryptophan uptake in your brain. It will take about 3 hours to complete the PET scan; this includes the completion of the questionnaire, preparation and scanning. The actual scanning time will be 70 minutes. If you are a female of child-bearing age, we will need a small urine sample from you before starting the PET scanning procedure to make absolutely sure that you do not have unknown pregnancy for which radiation exposure might be harmful.
- The PET scan will be used to measure the accumulation of the injected radioactive tracer AMT in your brain. To make this measurement more accurate, we will use your clinically obtained MRI scan(s), which was used to diagnose the tumor, to identify the exact location and extent of the tumor. For the PET scan, an intravenous catheter (a small tube placed in your vein) will be inserted for the injection of the AMT for this PET scan. It is the tracer that the PET scanner "sees" when performing the scan. The amount of the tracer, which will be given is very small (5 ml, the volume of a teaspoon), and therefore no side effects are expected from the tracer itself. A second intravenous catheter will be inserted to collect blood samples during the scan; a total of less than 2 teaspoons of blood will be collected. Participants may be sedated (put into sleep with some medicine) if they are unable to remain still for the scanning period.
- On the day of the PET scan, we will ask you to fill out a brief clinical questionnaire, and also an additional multiple-choice questionnaire to screen for potential mood problems (which often coincide with brain tumors). Participants with a potential speech (comprehension) problem will also be administered a brief speech test. The goal of these tests is to identify various clinical problems that can be associated with brain tumors and affected by abnormal tryptophan metabolism that we measure with the PET scan.
- If you have surgery to remove the tumor, a portion of the removed tissue will be used for biochemical studies. The doctor will not remove more tissue than needed for your care. The blood (obtained during the PET scanning) and tumor tissue (obtained during surgery) will be processed for analysis and stored in a locked container or freezer in a laboratory. In addition, we will review the clinical pathology report, so that we can correlate your PET results to type and grade of the tumor.
- Conditions
- Glioblastoma
- Keywords
- rGBM, Recurrent GBM, 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.
| Study group | Role | What they receive |
|---|---|---|
| NovoTTF | NovoTTF treatment will be administered as usual during the imaging study either in monotherapy or in combination with other treatments (initiated prior to NovoTTF therapy). The treatment plan or intervention will not be altered in any way. Two AMT-PET scans will be added to the management scheme: a baseline PET shortly before and a follow-up PET scan 2-3 months after the start of NovoTTF treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interval Changes of Tumoral Metabolism
To measure interval changes of tumoral metabolism, blood flow, and metabolites (NAA, choline, creatine, lipid, lactate) using AMT-PET, perfusion MRI, and 1H-MRS, respectively, in patients with recurrent GBM treated with NovoTTF.
Measured: 2-3 months
Secondary outcomes (1)
Interval changes of tumoral tryptophan metabolism
To evaluate if interval changes of tumoral tryptophan metabolism, perfusion, and/or metabolites as well as histopathologic features (e.g., blood vessel density) have a predictive value for progression-free and overall survival in patients treated with NovoTTF.
Measured: 2-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2015 (estimated)
- Study startJul 2014
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
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.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Collaborators
- NovoCure Ltd.
- Responsible party
- Principal investigator, Csaba Juhasz, Wayne State University
- Investigators
- Csaba Juhasz, MD, PhD, Principal investigator, Wayne State UniversitySandeep Mittal, MD, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02367482
- Sponsor's protocol ID
- Novocure rGBM AMT-PET
- Status last verified
- Mar 2025
- First submitted
- 12 Feb 2015
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tryptophan Metabolism in Human Brain Tumors: For Patients Whose Clinical Treatment Includes NovoTTF
- ClinicalTrials.gov ID
- NCT02367482
- Acronym / sponsor ID
- Novocure rGBM AMT-PET
- Conditions
- Glioblastoma
- Keywords
- rGBM, Recurrent GBM, Recurrent Glioblastoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Collaborators
- NovoCure Ltd.
- Study start
- Jul 2014 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 20 Feb 2015 (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.
In this research study, we will track the build-up of tryptophan, a radioactive tracer, in the brain using positron emission tomography (PET) scanning. Tryptophan, in its natural state, is an amino acid (one of the building blocks of proteins) that is normally present in the brain, and is used by the brain cells to create various other compounds. This process is altered in the presence of a brain tumor. By using a form of tryptophan marked with a small amount of radiation, we will be able to track this process during the course of the PET scan. This research will help determine if AMT PET is a useful method to recognize and differentiate between various types of brain tumors. In addition, to study the mechanisms of altered tryptophan uptake in the tumor and brain, we will also measure tryptophan levels and related molecules in your blood (obtained as a part of the PET procedure) and tumor tissue (in case you will have surgery to remove the tumor). This will help us to find new approaches to treat brain tumors in the future by altering abnormal tryptophan metabolism.
Detailed description
If you agree to take part in this research study, you will be asked to have:
- A PET scan, 2. brief clinical questionnaires, and 3. biochemical studies of blood and tumor tissue. You will also have a second PET scan later, 2-3 months after the start of NovoTTF therapy, to determine if there are changes in the tumor that can be detected by PET. Your ability to participate in the study will be based, in part, on the results of the magnetic resonance images (MRI) in your medical chart from earlier clinical procedures. Once we receive the results of the PET scan, these will be compared to the MRI in order to help us analyze the tryptophan uptake in your brain. It will take about 3 hours to complete the PET scan; this includes the completion of the questionnaire, preparation and scanning. The actual scanning time will be 70 minutes. If you are a female of child-bearing age, we will need a small urine sample from you before starting the PET scanning procedure to make absolutely sure that you do not have unknown pregnancy for which radiation exposure might be harmful.
- The PET scan will be used to measure the accumulation of the injected radioactive tracer AMT in your brain. To make this measurement more accurate, we will use your clinically obtained MRI scan(s), which was used to diagnose the tumor, to identify the exact location and extent of the tumor. For the PET scan, an intravenous catheter (a small tube placed in your vein) will be inserted for the injection of the AMT for this PET scan. It is the tracer that the PET scanner "sees" when performing the scan. The amount of the tracer, which will be given is very small (5 ml, the volume of a teaspoon), and therefore no side effects are expected from the tracer itself. A second intravenous catheter will be inserted to collect blood samples during the scan; a total of less than 2 teaspoons of blood will be collected. Participants may be sedated (put into sleep with some medicine) if they are unable to remain still for the scanning period.
- On the day of the PET scan, we will ask you to fill out a brief clinical questionnaire, and also an additional multiple-choice questionnaire to screen for potential mood problems (which often coincide with brain tumors). Participants with a potential speech (comprehension) problem will also be administered a brief speech test. The goal of these tests is to identify various clinical problems that can be associated with brain tumors and affected by abnormal tryptophan metabolism that we measure with the PET scan.
- If you have surgery to remove the tumor, a portion of the removed tissue will be used for biochemical studies. The doctor will not remove more tissue than needed for your care. The blood (obtained during the PET scanning) and tumor tissue (obtained during surgery) will be processed for analysis and stored in a locked container or freezer in a laboratory. In addition, we will review the clinical pathology report, so that we can correlate your PET results to type and grade of the tumor.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NovoTTF | – | –NovoTTF treatment will be administered as usual during the imaging study either in monotherapy or in combination with other treatments (initiated prior to NovoTTF therapy). The treatment plan or intervention will not be altered in any way. Two AMT-PET scans will be added to the management scheme: a baseline PET shortly before and a follow-up PET scan 2-3 months after the start of NovoTTF treatment. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients eligible and agreeable to undergo NovoTTF treatment at KCC/WSU due to recurrent glioblastoma (initial or subsequent tumor recurrence) will be recruited by the multidisciplinary neuro-oncology team to undergo the two AMT-PET studies.
Key inclusion criteria (5 listed)
- Clinical and MRI diagnosis of recurrent GBM.
- Age ≥22 years.
- Patient agrees to NovoTTF treatment but has not started treatment yet.
- Patient agrees to undergo a baseline and a follow-up AMT-PET scan during NovoTTF treatment.
- Patient able to provide informed consent.
Key exclusion criteria (3 listed)
- Resective surgery within 2 months prior to the initial AMT-PET scan (acute/subacute post-surgical inflammatory changes may cause false positive increased uptake on AMT-PET).
- Severe increased intracranial pressure, status epilepticus, or other severe complications of the tumor, requiring emergency or urgent intervention.
- Positive pregnancy test (because of radiation involved in PET scanning).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Interval Changes of Tumoral Metabolism
Time frame: 2-3 months
To measure interval changes of tumoral metabolism, blood flow, and metabolites (NAA, choline, creatine, lipid, lactate) using AMT-PET, perfusion MRI, and 1H-MRS, respectively, in patients with recurrent GBM treated with NovoTTF.
1 secondary outcome
Interval changes of tumoral tryptophan metabolism
Time frame: 2-3 months
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 20 Mar 2025.
- Individual participant dataSharing planned: No
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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.
Csaba Juhasz, MD, PhD principal investigator
Wayne State University
Sandeep Mittal, MD principal investigator
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioblastoma, run by Wayne State University 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 5 inclusion and 3 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 20 Mar 2025. 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?
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?
Interval Changes of Tumoral Metabolism (time frame: 2-3 months). 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 20 Mar 2025.