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A Comparative Study of Pediatric CNS Tumor Activity as Assessed by [18]F-FDG PET Imaging and Proton Magnetic Resonance Spectroscopic Imaging ([1]H-MRSI)

1 Year
21 Years
Open (Enrolling)
Brain Neoplasms

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Trial Information

A Comparative Study of Pediatric CNS Tumor Activity as Assessed by [18]F-FDG PET Imaging and Proton Magnetic Resonance Spectroscopic Imaging ([1]H-MRSI)


- 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.


- 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.


- 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.


- 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)

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


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

4. Any patient with a metallic MRI incompatible implant, including cardiac pacemakers,
neural pacemakers, aneurysmal clips, shrapnel, cochlear implants or ferrous surgical

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.

Type of Study:


Study Design:


Outcome Measure:

Single timepoint comparison as assessed by fludeoxyglucose F 189FDG) positron emission tomography (PET) vs nuclear magnetic resonance spectroscopy (NMRS).

Safety Issue:


Principal Investigator

Katherine E Warren, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)


United States: Federal Government

Study ID:




Start Date:

August 2003

Completion Date:

Related Keywords:

  • Brain Neoplasms
  • Brain Tumor
  • Children
  • Metabolic
  • Spectroscopy
  • PET
  • Brain Neoplasms
  • Neoplasms



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