Ignite Creation Date:
2024-05-06 @ 9:17 AM
Last Modification Date:
2024-10-26 @ 12:12 PM
Study NCT ID:
NCT02947373
Status:
COMPLETED
Last Update Posted:
2021-06-24
First Post:
2016-10-24
Brief Title:
Pilot Study of Safety and Toxicity of Acquiring Hyperpolarized Carbon-13 Imaging in Children With Brain Tumors
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
PNOC 011 Pilot Study of Safety and Toxicity of Acquiring Hyperpolarized Carbon-13 Imaging in Children With Brain Tumors
Status:
COMPLETED
Status Verified Date:
2021-06
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:
This is a single arm pilot trial within the Pacific Pediatric Neuro-Oncology Consortium PNOC
The pilot study will look at the safety and toxicity of acquiring hyperpolarized carbon-13 imaging in children with brain tumors
The pilot study will look at the safety and toxicity of acquiring hyperpolarized carbon-13 imaging in children with brain tumors
Detailed Description:
This is an open label trial to assess the safety and tolerability of the adult tolerated dose of Hyperpolarized Pyruvate HP for metabolic imaging in children with brain tumors who do not require sedation for their MR imaging Nine patients will receive a single MR imaging examination that includes the acquisition of hyperpolarized 13C metabolic data in combination with anatomic diffusion perfusion and lactate edited 1H spectroscopic imaging data The data will be processed using custom designed software to estimate changes in levels of lactatepyruvate and to relate them to abnormalities observed in the data from other MR modalities
The results of this study will provide the safety data required to move this type of metabolic imaging into therapeutic trials to assess the utility of HP 13C lactatepyruvate as a new surrogate marker of drug tumor penetration and early response to therapy in children with brain tumors
The results of this study will provide the safety data required to move this type of metabolic imaging into therapeutic trials to assess the utility of HP 13C lactatepyruvate as a new surrogate marker of drug tumor penetration and early response to therapy in children with brain tumors
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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 |
|---|---|---|---|
| 16088 | OTHER | University Of California San Francisco HDCC | None |