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Comparison of PET and Proton MRS Imaging to Evaluate Pediatric Brain Tumor Activity

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier:
NCT00067821
First received: August 28, 2003
Last updated: September 26, 2014
Last verified: September 2014
  Purpose

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.


Condition
Brain Neoplasms

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Compare results from Proton Magnetic Resonance Spectroscopic Imaging (1H-MRSI) and [18F]-FDG Positron Emission Tomography (PET) in brain tumors [ Time Frame: One scan each/year X 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlate results of compare results from Proton Magnetic Resonance Spectroscopic Imaging (1H-MRSI) and [18F]- FDG Positron Emission Tomography (PET) with MRI [ Time Frame: One scan each/year X 5 years ] [ Designated as safety issue: Yes ]
  • To evaluate changes over time in brain tumors [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 75
Study Start Date: August 2003
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 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)
  Eligibility

Ages Eligible for Study:   1 Year to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00067821

Contacts
Contact: Katherine E Warren, M.D. (301) 435-4683 warrenk@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office    (888) NCI-1937      
Sponsors and Collaborators
Investigators
Principal Investigator: Katherine E Warren, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier: NCT00067821     History of Changes
Obsolete Identifiers: NCT00070512
Other Study ID Numbers: 030278, 03-C-0278
Study First Received: August 28, 2003
Last Updated: September 26, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Brain Tumor
Children
Metabolic
Spectroscopy
PET

Additional relevant MeSH terms:
Brain Neoplasms
Brain Diseases
Central Nervous System Diseases
Central Nervous System Neoplasms
Neoplasms
Neoplasms by Site
Nervous System Diseases
Nervous System Neoplasms

ClinicalTrials.gov processed this record on November 23, 2014