Ignite Creation Date:
2024-05-05 @ 9:53 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001574
Status:
COMPLETED
Last Update Posted:
2019-05-08
First Post:
1999-11-03
Brief Title:
A Pilot Study of 1H-Nuclear Magnetic Resonance Spectroscopic Imaging in Pediatric Patients With Primary and Metastatic Brain Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Pilot Study of 1H-Nuclear Magnetic Resonance Spectroscopic Imaging in Pediatric Patients With Primary and Metastatic Brain Tumors
Status:
COMPLETED
Status Verified Date:
2019-05-06
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:
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
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| 97-C-0093 | None | None | None |