Brain Cancer Clinical Trial
Official title:
A Pilot Study of 1H-Nuclear Magnetic Resonance Spectroscopic Imaging in Pediatric Patients With Primary and Metastatic Brain Tumors
NCT number | NCT00001574 |
Other study ID # | 970093 |
Secondary ID | 97-C-0093 |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 14, 1997 |
Est. completion date | May 6, 2019 |
Verified date | May 6, 2019 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | May 6, 2019 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 21 Years |
Eligibility |
- 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. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Castillo M, Kwock L, Mukherji SK. Clinical applications of proton MR spectroscopy. AJNR Am J Neuroradiol. 1996 Jan;17(1):1-15. Review. — View Citation
Duyn JH, Gillen J, Sobering G, van Zijl PC, Moonen CT. Multisection proton MR spectroscopic imaging of the brain. Radiology. 1993 Jul;188(1):277-82. — View Citation
Sutton LN, Wang Z, Gusnard D, Lange B, Perilongo G, Bogdan AR, Detre JA, Rorke L, Zimmerman RA. Proton magnetic resonance spectroscopy of pediatric brain tumors. Neurosurgery. 1992 Aug;31(2):195-202. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To define specific patterns of metabolises using long-echo time multislice proton nuclear magnetic resonance spectroscopic imaging in pediatric patients with brain tumors. | in vivo measurements of tissue metabolites (NAA, Cho,Cr, Lac) and what they reflect | at time of disease evaluation | |
Secondary | Distinguish spectroscopic patterns associated with tumor progression, necrosis and edema | measurements and differences of signal intensity of peaks obtained for tissue metabolites (NAA, Cho, Cr, Lac) | at time of disease evaluation | |
Secondary | Determine if early metabolic changes are predictive of response | Contalateral spectroscopic analysis results, stratified according to type of tumor, history of radiation therapy or surgery | at time of disease evaluation |
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