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A Pilot Study of 1H-Nuclear Magnetic Resonance Spectroscopic Imaging in Pediatric Patients With Primary and Metastatic Brain Tumors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00001574
First Posted: November 4, 1999
Last Update Posted: October 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
  Purpose

Brain tumors represent the most common solid tumor of childhood. Treatment generally entails surgery and radiation, but local recurrence is frequent. Chemotherapy is often used in an adjuvant setting, to delay radiation therapy or for resistant disease. Children with brain tumors are generally followed by imaging studies, such as CT or MRI. Difficulty arises in trying to distinguish tumor regrowth from treatment related edema, necrosis or radiation injury. Proton Nuclear Magnetic Resonance Spectroscopic (NMRS) Imaging is a non-invasive method of detecting and measuring cellular metabolites in vivo. NMRS imaging complements routine MRI by giving chemical information in conjunction with spatial information obtained by MRI.

This study will be conducted to determine NMRS imaging patterns before, during and after chemotherapy in pediatric patients with primary or metastatic brain tumors in an attempt to identify and characterize specific patterns of metabolites related to tumor regrowth, tumor response to therapy, edema or necrosis.


Condition
Brain Neoplasm Brain Cancer Brain Tumor, Primary

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Pilot Study of 1H-Nuclear Magnetic Resonance Spectroscopic Imaging in Pediatric Patients With Primary and Metastatic Brain Tumors

Resource links provided by NLM:


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

Primary Outcome Measures:
  • To define specific patterns of metabolises using long-echo time multislice proton nuclear magnetic resonance spectroscopic imaging in pediatric patients with brain tumors. [ Time Frame: at time of disease evaluation ]

Secondary Outcome Measures:
  • Distinguish spectroscopic patterns associated with tumor progression, necrosis and edema [ Time Frame: at time of disease evaluation ]
  • Determine if early metabolic changes are predictive of response [ Time Frame: at time of disease evaluation ]

Enrollment: 40
Study Start Date: March 14, 1997
Detailed Description:

Background:

  • Brain tumors represent the most common solid tumor of childhood. Treatment generally includes surgery and radiation, but recurrences are frequent, particularly for high-grade lesions.
  • Chemotherapy is often used in an adjuvant setting, to delay radiation therapy or for resistant disease.
  • Children with brain tumors are generally followed by imaging studies, such as CT or MRI.
  • Difficulty arises in trying to distinguish tumor regrowth from treatment related edema, necrosis or radiation injury.
  • Proton Nuclear Magnetic Resonance Spectroscopic (NMRS) Imaging is a non-invasive method of detecting and measuring cellular metabolites in vivo.

Objective:

  • To determine NMRS imaging patterns before, during and after chemotherapy in pediatric patients with primary or metastatic brain tumors
  • To identify and characterize specific patterns of metabolites related to tumor regrowth, tumor response to therapy, edema or necrosis.

Eligibility:

  • Age less than or equal to 21 years.
  • Patients entered on this trial will also be entered on one of the Branch s primary brain tumor treatment trials.
  • Histologically confirmed primary or metastatic brain tumor. Patients with a brainstem glioma or optic pathway gliomas are not required to have a histologic diagnosis.
  • Measurable or evaluable tumor at the time of study entry.

Design:

  • This is intended to be a pilot study to define metabolite patterns associated with tumor growth, tumor edema and tumor necrosis as seen on standard MRI; and determine the feasibility of using metabolite patterns to predict response to therapy in pediatric patients with brain tumors.
  • Contalateral spectroscopic analysis of normal appearing brain will also be performed when feasible.
  • Analysis of results will be stratified according to type of tumor, and prior history of radiation therapy or surgery.
  Eligibility

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Age less than or equal to 21 years.

Patients entered on this trial will also be entered on one of the Pediatric Oncology Branch's primary treatment trials (e.g., phenylacetate, phenylbutyrate, SU-101) or on the Natural History or Standard Therapy protocols. The patient's management will be determined by the primary treatment protocol.

Histology confirmed primary or metastatic brain tumor. Patients with a brainstem glioma are not required to have previously had a histologic diagnosis.

Measurable or evaluable tumor at the time of study entry.

Durable Power of Attorney (DPA): A DPA is required of all patients 18 - 21 years of age.

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 give verbal assent.

EXCLUSION CRITERIA:

Pregnant women.

Any patient who is unable (either because of physical or psychological factors) to undergo imaging studies and who is not an anesthesia candidate.

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

Any patient with a history of a severe reaction to Gadolinium or other contrast agents.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001574


Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Katherine E Warren, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Publications:
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00001574     History of Changes
Obsolete Identifiers: NCT00019292
Other Study ID Numbers: 970093
97-C-0093
First Submitted: November 3, 1999
First Posted: November 4, 1999
Last Update Posted: October 6, 2017
Last Verified: July 15, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Metabolites
Proton Nuclear Magnetic Resonance Spectroscopic Imaging
Scans

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