An observational study in Brain Cancer and Brain Neoplasms, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to participants aged 4 Years to 20 Years. Per ClinicalTrials.gov, last updated 2019-04-24.
Sponsored by National Cancer Institute (NCI) · Observational
Central nervous system toxicity is a recognized side effect of certain therapies for cancers, particularly cranial irradiation, intrathecal therapy or systemic high-dose chemotherapy. The pathophysiologic mechanisms and clinical manifestations vary. Previous studies defining MRI changes and correlating these with neurocognitive deficiencies have been inconsistent. Recent advances in brain imaging may help to better define neurotoxic effects. (1)H-NMRS is a noninvasive method of obtaining in vivo biochemical information from the brain. It has been used to study patients with CNS disorders, including neuronal disorders. In this study, (1)H-NMRS will be used to objectively characterize CNS toxicities in patients with cancer who are receiving potentially neurotoxic therapies. In addition, we will retrospectively evaluate patients with known or suspected neurotoxicity associated with cancer therapy, to determine if changes in spectroscopic patterns are associated with CNS toxicity.
Background:
Objective:
-To identify specific patterns of brain metabolites that are associated with therapy-related neurotoxicity using (1)H-NMRS in cancer patients who are receiving or have received potentially neurotoxic therapy.
Eligibility:
-Patients with brain tumors or patients receiving high-dose systemic chemotherapy, intrathecal chemotherapy (lumbar puncture or intra-Ommaya), or cranial radiation therapy OR patients with documented or suspected clinical neurotoxicity presumed to be caused by treatment for cancer.
Design:
1,960 studies on the registry are indexed under Brain Neoplasms; 515 are open to participants now.
This study's enrollment of 50 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.
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Patients with brain tumors or patients receiving high-dose systemic chemotherapy, intrathecal chemotherapy (lumbar puncture or intra-Ommaya), or cranial radiation therapy or patients with documented or suspected clinical neurotoxicity presumed to be caused by treatment for cancer.
Durable Power of Attorney (DPA) should be offered to all patients greater than or equal to 18 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 sign a written assent.
EXCLUSION CRITERIA:
Pregnancy.
Patients with braces or permanent retainers.
Patients with pre-existing neurologic or genetic conditions, unrelated to the tumor.
Patients who are unable (either because of physical or psychological factors) to undergo imaging studies and who are not a candidate for anesthesia.
Patients who have an absent gag reflex or swallowing difficulties.
Metallic implants, including cardiac pacemakers, neural pacemakers, shrapnel, cochlear implants or ferrous surgical clips.
History of severe reaction to Gadolinium.
Identify patterns of brain metabolites associated with therapy related neurotoxicity
changes in spectroscopic metabolite patterns defined by neuropsychological testing or abnormalities on conventional MRI
Time frame: At time of MRI and till date of death
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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National Cancer Institute (NCI)