Clinical Trial
PNOC011: Pilot study of the safety and toxicity of acquiring hyperpolarized carbon-13 imaging in children with brain tumors
Please note, this study has closed to accrual and is no longer accepting patients. || This is an open label trial to assess the safety and tolerability of the adult-tolerated dose of hyperpolarized pyruvate for metabolic imaging in children with brain tumors who do not require sedation for their MR imaging. 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 lactate/pyruvate 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 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.
Please note, this study has closed to accrual and is no longer accepting patients. || This is an open label trial to assess the safety and tolerability of the adult-tolerated dose of hyperpolarized pyruvate for metabolic imaging in children with brain tumors who do not require sedation for their MR imaging. 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 lactate/pyruvate 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 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.