Pilot Study of Safety and Toxicity of Acquiring Hyperpolarized Carbon-13 Imaging in Children With Brain Tumors

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
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.

Inclusion Criteria:

- Children ≥ 3 years and ≤ 18 years of age with a diagnosis of a brain tumor and who do
not require sedation for MR imaging

- Karnofsky ≥ 70 for patients ≥ 16 years of age, and Lansky ≥ 70 for patients < 16 years
of age (See Appendix 1 Performance Status Criteria)

- Patients must not have any significant medical illnesses that in the investigator's
opinion cannot be adequately controlled with appropriate therapy, would compromise the
patient's ability to tolerate the imaging examination or any disease that will obscure
toxicity or dangerously alter response to the imaging agent

- Patients must not be pregnant or breast feeding. Women of childbearing potential are
required to obtain a negative pregnancy test within 14 days of starting treatment.
Effective contraception (men and women) must be used in subjects of child-bearing
potential

- Ability to understand and the willingness of the patient, parent or legal guardian to
provide informed consent

Exclusion Criteria:

- Patients who are not able to comply with study and/or follow-up procedures

- Patients receiving active therapy on an investigational trial at the time of
enrollment should consult with the study chair regarding potential interactions with
other study agents. Patients who are enrolled in a clinical trial but are off- therapy
and in follow up are eligible.

- Patients with history or evidence of cardiac dysfunction