Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001807
Status:
COMPLETED
Last Update Posted:
2019-04-24
First Post:
1999-11-03
Brief Title:
1H-Nuclear Magnetic Resonance Spectroscopic Imaging of the Brain in Patients Who Receive Neurotoxic Therapy
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
1H-Nuclear Magnetic Resonance Spectroscopic Imaging of the Brain in Patients Who Receive Neurotoxic Therapy
Status:
COMPLETED
Status Verified Date:
2019-04-18
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 1H-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 1H-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
Detailed Description:
Background
Central nervous system toxicity is a recognized side effect of certain cancer therapies particularly cranial irradiation intrathecal therapy and systemic high-dose chemotherapy
The pathophysiologic mechanisms are not well-defined 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 1H-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
Objective
-To identify specific patterns of brain metabolites that are associated with therapy-related neurotoxicity using 1H-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
In order to identify metabolite profiles that may be associated with neurotoxicity NMRS data will be collected in a cross-sectional manner from patients at various stages of treatment and longitudinally throughout the course of therapy
NMRS studies will be performed on patients entered on this study at any or all of the following times prior to therapy immediately after the first cycle of therapy prior to subsequent cycles of therapy or after completion of all therapy
Neurotoxicity will also be evaluated by neuropsychological testing
Central nervous system toxicity is a recognized side effect of certain cancer therapies particularly cranial irradiation intrathecal therapy and systemic high-dose chemotherapy
The pathophysiologic mechanisms are not well-defined 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 1H-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
Objective
-To identify specific patterns of brain metabolites that are associated with therapy-related neurotoxicity using 1H-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
In order to identify metabolite profiles that may be associated with neurotoxicity NMRS data will be collected in a cross-sectional manner from patients at various stages of treatment and longitudinally throughout the course of therapy
NMRS studies will be performed on patients entered on this study at any or all of the following times prior to therapy immediately after the first cycle of therapy prior to subsequent cycles of therapy or after completion of all therapy
Neurotoxicity will also be evaluated by neuropsychological testing
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 99-C-0088 | None | None | None |