Brain TumorsNCT00067821
Comparison of PET and Proton MRS Imaging to Evaluate Pediatric Brain Tumor Activity
An observational study of Brain Tumors, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This study in children and young adults will compare two types of imaging, positron emission tomography ([(18)F]-DG PET) and proton magnetic resonance spectroscopy ((1)H-MRSI), to determine activity of a brain tumor or abnormal tissue in the brain following treatment for a brain tumor. Read more about this study
- Who is it for?
- Ages 1 year to 21 years
- Conditions the study is for
- Brain Tumors
- What is being tested?
- 2-Flourodeoxyglucose
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2014to 10 May 2019
- 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 1 year to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients must have a brain tumor (including, but not limited to high grade gliomas, low-grade gliomas, primitive neuroectodermal tumors, ependymomas) or residual abnormality (e.g. post-operatively or post-radiation) that is measurable or evaluable on standard MRI or CT
Who may be able to join
- Age: greater than or equal to 1 years and less than or equal to 21 years.
- Radiographic diagnosis: Patients must have a brain tumor (including, but not limited to high grade gliomas, low-grade gliomas, primitive neuroectodermal tumors, ependymomas) or residual abnormality (e.g. post-operatively or post-radiation) that is measurable or evaluable on standard MRI or CT.
- All patients or their legal guardians (if the patient is less than 18 years of age) must sign a document of informed consent indicating their awareness of the investigational nature and the risks of this study.
- Prior treatment: Patients will be eligible regardless of prior treatment. Therefore, patients who are newly diagnosed, post-operative, post-radiation or post-chemotherapy are eligible.
Who cannot join
- Patients under age 18 years who weigh greater than 70 kg are excluded because they would exceed the standard allowable dosimetry for pediatric patients (i.e. Effective Dose greater than 0.5 REM/year). In addition, patients who weigh greater than 136 kg are excluded, as this is the maximum weight allowable on PET scanner tables.
- Pregnant or breastfeeding women
- Any patient who is unable (either because of physical or psychological factors) to undergo imaging studies without sedation but is not considered an anesthesia candidate.
- Any patient with a metallic MRI incompatible implant, including cardiac pacemakers, neural pacemakers, aneurysmal clips, shrapnel, cochlear implants or ferrous surgical clips.
- Any patient with a history of a severe reaction (CTC v.4 Grade greater than or equal to 2) to Gadolinium or other contrast agents.
- Any patient with Diabetes mellitus or steroid-induced hyperglycemia (fasting glucose greater than 150) because this may interfere with the interpretation of the [(18)F]-FDG PET scan.
- Any patient with permanent braces, permanent retainers or nonferrous implant that, in the judgment of the Principal Investigator, would interfere with obtaining spectroscopy in the area of the tumor.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: A Comparative Study of Pediatric CNS Tumor Activity as Assessed by 18F-FDG PET Imaging and Proton Magnetic Resonance Spectroscopic Imaging (1H-MRSI)
This study in children and young adults will compare two types of imaging, positron emission tomography ([(18)F]-DG PET) and proton magnetic resonance spectroscopy ((1)H-MRSI), to determine activity of a brain tumor or abnormal tissue in the brain following treatment for a brain tumor. Children with brain tumors are generally followed with magnetic resonance imaging (MRI) scans to evaluate response to treatment. However, because MRI only provides information on the structure of the brain, it may difficult to tell if an abnormal finding is due to tumor, swelling, scar tissue, or dead tissue. (1)H-MRSI and [(18)F]-DG PET, on the other hand, provide information on the metabolic activity of brain lesions. These two methods will be compared and evaluated for their ability to provide important additional information on childhood brain tumors.
Patients between 1 and 21 years of age with a brain tumor or brain tissue abnormality following treatment for a brain tumor may be eligible for this study. Candidates will be screened with a medical history and physical examination, pregnancy test in women who are able to become pregnant, and a blood test for glucose.
Read more
Participants will undergo the following procedures:
(1)H-MRSI - This test is similar to MRI and is done in the same scanning machine. In MRI, scans of the brain are obtained by applying a strong magnetic field and then collecting the signals released from water after the magnetic field is changed. Pictures of the brain are then obtained by computer analysis of these signals. In (1)H-MRSI, the computer blocks the signal from water to get information on brain chemicals that can indicate whether an abnormality is tumor or dead tissue. Both MRI and MRI and (1)H-MRSI are done in this study.
For these tests, the child lies on a stretcher that moves into the scanner - a narrow metal cylinder with a strong magnetic field. The child's head is placed in a headrest to prevent movement during the scan. He or she will hear loud thumping noises caused by the electrical switching of the magnetic field. A contrast agent is given through an intravenous (IV) catheter (plastic tube placed in an arm vein) or through a central line if one is in place. The contrast material brightens the images to provide a clearer picture of abnormalities. Children who have difficulty holding still or being in a scanning machine are given medications by an anesthesiologist to make them sleep through the procedure. Children who are awake during the procedure can communicate with the MRI technician at all times and ask to be removed from the scanner at any time. The MRI and (1)H-MRSI take 1-1/2 to 2 hours to complete.
[(18)F]-DG PET - For this test, [(18)F]-DG (a radioactive form of glucose) is injected into the patient's arm vein through a catheter, followed by the PET scan, similar to a very open MRI scan without the noise. The PET scan tells how active the patient's tumor is by tracking the radioactive glucose. All cells use glucose, but cells with increased metabolism, such as cancer cells, use more glucose than normal cells. After the glucose injection, the patient lies quietly in a darkened room for 30 minutes, after which he or she is asked to urinate to help reduce the dose of radiation to the bladder. Then, the scan begins. When the scan is finished (after about 1 hour), the child is asked to urinate again and then every 3 to 4 hours for the rest of the day.
Patients remain in the study for 2 years unless they withdraw, become pregnant, or require sedation but can no longer use an anesthetic. MRI and 1H-MRSI scans may be repeated every few months during the study period, if necessary. Only one PET scan is done each year.
Read the detailed description
Background:
- Children with brain tumors are generally followed for response or progression by imaging studies, such as CT or MRI.
- While these imaging studies help delineate the anatomical location and extent of a tumor within the CNS, they give no information regarding the biologic or metabolic activity of the lesion.
- Proton Nuclear Magnetic Resonance Spectroscopic Imaging ((1)H-MRSI) is a non-invasive method of detecting and measuring cellular metabolites in vivo, providing biochemical information in conjunction with the spatial information obtained by MRI.
- Positron Emission Tomography (PET) is a technique that also provides data on metabolic activity of brain lesions.
- A comparison of these two methods in determining a lesion s metabolic activity has not been reported in children with brain tumors.
Objective:
-To compare (1)H-MRSI and [(18)F-]-FDG PET scanning percentage (%) of agreement between supratentorial and infratentorial tumors, and between brainstem and cerebellum intratentorial tumors.
Eligibility:
- Age: greater than or equal to 1 year and less than to 21 years
- Patients must have a brain tumor that is measurable or evaluable on standard MRI or CT.
Design:
- Patients referred for this study will have both (1)H-MRSI and (18)F-FDG PET imaging performed within 2 weeks of each other at the NCI
- Patients will remain on study for 5 years or until one of the off-study criteria have been met (whichever occurs first)
- Conditions
- Brain Tumors
- Being tested
- 2-Flourodeoxyglucose
- Keywords
- Brain Tumor, Children, Metabolic, Spectroscopy, PET, Natural History
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2-FlourodeoxyglucoseDrug
| Study group | Role | What they receive |
|---|---|---|
| 1/Patients | Must have a brain tumor, or residual abnormality that is measurable or evaluable on standard MRI or CT Receives: Drug: 2-Flourodeoxyglucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison
compare results from Proton Magnetic Resonance Spectroscopic Imaging (1H-MRSI) and [18F]-FDG Positron Emission Tomography (PET) in brain tumors
Measured: one scan each/year X 5 years
Secondary outcomes (2)
Evaluate change
To evaluate changes over time in brain tumors
Measured: 5 years
Comparison
correlate results of compare results from Proton Magnetic Resonance Spectroscopic Imaging (1H-MRSI) and [18F]-FDG Positron Emission Tomography (PET) with MRI
Measured: one scan each/year X 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2003 (estimated)
- Study start11 Feb 2014
- Primary completion10 May 2019
- Study completion10 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorsStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- John W Glod, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00067821
- Sponsor's protocol ID
- 030278
- Other IDs
- 03-C-0278
- Status last verified
- Jun 2023
- First submitted
- 28 Aug 2003
- Last updated
- 13 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: .All IPD recorded in the medical record will be shared with intramural investigators upon request.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Pediatric CNS Tumor Activity as Assessed by 18F-FDG PET Imaging and Proton Magnetic Resonance Spectroscopic Imaging (1H-MRSI)
- ClinicalTrials.gov ID
- NCT00067821
- Acronym / sponsor ID
- 030278
- Conditions
- Brain Tumors
- Keywords
- Brain Tumor, Children, Metabolic, Spectroscopy, PET, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 11 Feb 2014 (actual)
- Primary completion
- 10 May 2019 (actual)
- Study completion
- 10 May 2019 (actual)
- First posted
- 28 Aug 2003 (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 study in children and young adults will compare two types of imaging, positron emission tomography ([(18)F]-DG PET) and proton magnetic resonance spectroscopy ((1)H-MRSI), to determine activity of a brain tumor or abnormal tissue in the brain following treatment for a brain tumor. Children with brain tumors are generally followed with magnetic resonance imaging (MRI) scans to evaluate response to treatment. However, because MRI only provides information on the structure of the brain, it may difficult to tell if an abnormal finding is due to tumor, swelling, scar tissue, or dead tissue. (1)H-MRSI and [(18)F]-DG PET, on the other hand, provide information on the metabolic activity of brain lesions. These two methods will be compared and evaluated for their ability to provide important additional information on childhood brain tumors.
Patients between 1 and 21 years of age with a brain tumor or brain tissue abnormality following treatment for a brain tumor may be eligible for this study. Candidates will be screened with a medical history and physical examination, pregnancy test in women who are able to become pregnant, and a blood test for glucose.
Participants will undergo the following procedures:
(1)H-MRSI - This test is similar to MRI and is done in the same scanning machine. In MRI, scans of the brain are obtained by applying a strong magnetic field and then collecting the signals released from water after the magnetic field is changed. Pictures of the brain are then obtained by computer analysis of these signals. In (1)H-MRSI, the computer blocks the signal from water to get information on brain chemicals that can indicate whether an abnormality is tumor or dead tissue. Both MRI and MRI and (1)H-MRSI are done in this study.
For these tests, the child lies on a stretcher that moves into the scanner - a narrow metal cylinder with a strong magnetic field. The child's head is placed in a headrest to prevent movement during the scan. He or she will hear loud thumping noises caused by the electrical switching of the magnetic field. A contrast agent is given through an intravenous (IV) catheter (plastic tube placed in an arm vein) or through a central line if one is in place. The contrast material brightens the images to provide a clearer picture of abnormalities. Children who have difficulty holding still or being in a scanning machine are given medications by an anesthesiologist to make them sleep through the procedure. Children who are awake during the procedure can communicate with the MRI technician at all times and ask to be removed from the scanner at any time. The MRI and (1)H-MRSI take 1-1/2 to 2 hours to complete.
[(18)F]-DG PET - For this test, [(18)F]-DG (a radioactive form of glucose) is injected into the patient's arm vein through a catheter, followed by the PET scan, similar to a very open MRI scan without the noise. The PET scan tells how active the patient's tumor is by tracking the radioactive glucose. All cells use glucose, but cells with increased metabolism, such as cancer cells, use more glucose than normal cells. After the glucose injection, the patient lies quietly in a darkened room for 30 minutes, after which he or she is asked to urinate to help reduce the dose of radiation to the bladder. Then, the scan begins. When the scan is finished (after about 1 hour), the child is asked to urinate again and then every 3 to 4 hours for the rest of the day.
Patients remain in the study for 2 years unless they withdraw, become pregnant, or require sedation but can no longer use an anesthetic. MRI and 1H-MRSI scans may be repeated every few months during the study period, if necessary. Only one PET scan is done each year.
Detailed description
Background:
- Children with brain tumors are generally followed for response or progression by imaging studies, such as CT or MRI.
- While these imaging studies help delineate the anatomical location and extent of a tumor within the CNS, they give no information regarding the biologic or metabolic activity of the lesion.
- Proton Nuclear Magnetic Resonance Spectroscopic Imaging ((1)H-MRSI) is a non-invasive method of detecting and measuring cellular metabolites in vivo, providing biochemical information in conjunction with the spatial information obtained by MRI.
- Positron Emission Tomography (PET) is a technique that also provides data on metabolic activity of brain lesions.
- A comparison of these two methods in determining a lesion s metabolic activity has not been reported in children with brain tumors.
Objective:
-To compare (1)H-MRSI and [(18)F-]-FDG PET scanning percentage (%) of agreement between supratentorial and infratentorial tumors, and between brainstem and cerebellum intratentorial tumors.
Eligibility:
- Age: greater than or equal to 1 year and less than to 21 years
- Patients must have a brain tumor that is measurable or evaluable on standard MRI or CT.
Design:
- Patients referred for this study will have both (1)H-MRSI and (18)F-FDG PET imaging performed within 2 weeks of each other at the NCI
- Patients will remain on study for 5 years or until one of the off-study criteria have been met (whichever occurs first)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1/Patients | – | Drug: 2-FlourodeoxyglucoseMust have a brain tumor, or residual abnormality that is measurable or evaluable on standard MRI or CT |
Who may qualify
- Ages
- 1 year to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients must have a brain tumor (including, but not limited to high grade gliomas, low-grade gliomas, primitive neuroectodermal tumors, ependymomas) or residual abnormality (e.g. post-operatively or post-radiation) that is measurable or evaluable on standard MRI or CT
Key inclusion criteria (4 listed)
Key exclusion criteria (7 listed)
- Patients under age 18 years who weigh greater than 70 kg are excluded because they would exceed the standard allowable dosimetry for pediatric patients (i.e. Effective Dose greater than 0.5 REM/year). In addition, patients who weigh greater than 136 kg are excluded, as this is the maximum weight allowable on PET scanner tables.
- Pregnant or breastfeeding women
- Any patient who is unable (either because of physical or psychological factors) to undergo imaging studies without sedation but is not considered an anesthesia candidate.
- Any patient with a metallic MRI incompatible implant, including cardiac pacemakers, neural pacemakers, aneurysmal clips, shrapnel, cochlear implants or ferrous surgical clips.
- Any patient with a history of a severe reaction (CTC v.4 Grade greater than or equal to 2) to Gadolinium or other contrast 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 |
|---|---|---|
| 2-Flourodeoxyglucose | Drug | 1/Patients |
Primary outcome
Comparison
Time frame: one scan each/year X 5 years
compare results from Proton Magnetic Resonance Spectroscopic Imaging (1H-MRSI) and [18F]-FDG Positron Emission Tomography (PET) in brain tumors
2 secondary outcomes
Evaluate change
Time frame: 5 years
Comparison
Time frame: one scan each/year X 5 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 Jun 2023.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. .All IPD recorded in the medical record will be shared with intramural investigators upon request.
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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.
John W Glod, M.D. principal investigator
National Cancer Institute (NCI)
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 Brain Tumors, run by National Cancer Institute (NCI) 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 4 inclusion and 7 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 Jun 2023. 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?
Comparison (time frame: one scan each/year X 5 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 Jun 2023.