An observational study in Brain Neoplasm, Brain Cancer and Brain Tumor, Primary, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to participants aged Up to 21 Years. Per ClinicalTrials.gov, last updated 2019-05-08.
Sponsored by National Cancer Institute (NCI) · 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.
Background:
Objective:
Eligibility:
Design:
1,960 studies on the registry are indexed under Brain Neoplasms; 516 are open to participants now.
This study's enrollment of 40 is below the median of 100 across 380 observational studies indexed under Brain Neoplasms.
Browse Brain Neoplasms studies →National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.
Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
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
Time frame: at time of disease evaluation
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)
Time frame: at time of disease evaluation
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
Time frame: at time of disease evaluation
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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National Cancer Institute (NCI)