| Conditions: |
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Brain Neoplasms |
| Purpose: |
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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.
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| Study Summary: |
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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 biologic or metabolic activity of brain tumors in pediatric patients as
determined by (1)H-MRSI and [(18)F-]-FDG PET scanning
- To correlate results of (1)H-MRSI and (18)F-FDG PET imaging with outcome.
- To use [(18)F-]-FDG PET, (1)H-MRSI and various MR sequences to evaluate changes over
time in primary brain tumors as a result of the natural history of the lesion or
therapeutic effects.
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)
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| Criteria: |
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- INCLUSION CRITERIA:
1. Age: greater than or equal to 1 years and less than or equal to 21 years.
2. 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.
3. 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. When appropriate, the minor
patient will be asked for oral assent. The parent or guardian will sign the
consent form on the designated line attesting to the fact that the minor has
given assent.
4. Durable Power of Attorney (DPA): A DPA will be offered to all patients 18-21
years of age.
5. Prior treatment: Patients will be eligible for this study regardless of prior
treatment, as long as they meet other eligibility criteria. Therefore, patients
who are newly diagnosed, post-operative, post-radiation or post-chemotherapy are
eligible.
EXCLUSION CRITERIA:
1. 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.
2. Pregnant women are excluded because the effects from the magnet on the fetus are
unknown. In addition, gadolinium is not approved for use in pregnant women, because
its teratogenic effects have not been studied and we wish to avoid radiation exposure
to the fetus.
3. 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.
4. Any patient with a metallic MRI incompatible implant, including cardiac pacemakers,
neural pacemakers, aneurysmal clips, shrapnel, cochlear implants or ferrous surgical
clips.
5. 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.
6. 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.
7. 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.
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| NCT ID: |
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NCT00067821 |
| Primary Contact: |
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Principal Investigator
Katherine E Warren, M.D.
National Cancer Institute (NCI)
Katherine E Warren, M.D.
Phone: (301) 435-4683
Email: warrenk@mail.nih.gov
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| Backup Contact: |
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N/A |
| Location Contact: |
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Bethesda, Maryland 20892
United States
For more information at the NIH Clinical Center contact National Cancer Institute Referral Office
Phone: (888) NCI-1937
Site Status: Recruiting |