Clinical Trial
PNOC011: Pilot study of the safety and toxicity of acquiring hyperpolarized carbon-13 imaging in children with brain tumors
PNOC011 Study Publication
PNOC011 is now closed, and clinical trial results are now available as published in the AJNR – American Journal of Neuroradiology in January 2021.
viewable here:
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 lactate/pyruvate as a new surrogate marker of drug tumor penetration and early response to therapy in children with brain tumors. The availability of such imaging markers for determining whether treatment is successfully modulating the tumor or whether alternative approaches should be considered will be critical for a disease area with limited therapy options.
PRIMARY OBJECTIVES
The primary objective of this study is to determine the safety and tolerability of the established adult dose of hyperpolarized 13C in children ≥ 3 years and ≤ 18 years of age with brain tumors who do not require sedation for MR imaging.
SECONDARY OBJECTIVES
To assess imaging quality and define the most appropriate imaging parameters for obtaining HP 13C data from pediatric brain
Funding is provided by Kure-It.
PNOC011 Study Publication
PNOC011 is now closed, and clinical trial results are now available as published in the AJNR – American Journal of Neuroradiology in January 2021.
viewable here:
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 lactate/pyruvate as a new surrogate marker of drug tumor penetration and early response to therapy in children with brain tumors. The availability of such imaging markers for determining whether treatment is successfully modulating the tumor or whether alternative approaches should be considered will be critical for a disease area with limited therapy options.
PRIMARY OBJECTIVES
The primary objective of this study is to determine the safety and tolerability of the established adult dose of hyperpolarized 13C in children ≥ 3 years and ≤ 18 years of age with brain tumors who do not require sedation for MR imaging.
SECONDARY OBJECTIVES
To assess imaging quality and define the most appropriate imaging parameters for obtaining HP 13C data from pediatric brain
Funding is provided by Kure-It.
Sites Offering This Trial
- San Francisco, CA UCSF Benioff Children’s Hospitals
How to Enroll
If you believe your child or patient is eligible for this trial, contact the closest participating site or email us for more information.