UCSF BTC Clinical Trials

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

 

Summary

This study will look at the safety and toxicity of hyperpolarized carbon-13 imaging in children with brain tumors.

Hyperpolarized carbon-13 imaging is a type of metabolic imaging that relies on the injection of a traceable probe (like hyperpolarized pyruvate) to track metabolic events. This type of imaging can identify tumors, which use and metabolize nutrients differently than normal cells. Further, the goal is to also use this imaging technology to monitor a tumor’s response to treatment, and adjust treatment accordingly. For example, hyperpolarized carbon-13 imaging can help clinicians determine how well a treatment is working, by tracking changes in metabolism at the tumor site.

This Phase I clinical trial will assess the safety and tolerability of hyperpolarized pyruvate (at the dose tolerated by adults) for metabolic imaging in children with brain tumors. Each participant will receive a one-time injection of hyperpolarized pyruvate prior to a single MR imaging session that includes hyperpolarized carbon-13 imaging.

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 hyperpolarized carbon-13 imaging for monitoring early response to therapy in children with brain tumors.

Because changes in metabolism happen quickly, hyperpolarized carbon-13 imaging could potentially allow doctors to determine more quickly whether a drug is working or not. For children with brain tumors, this could make a meaningful difference in choosing to exchange one treatment regimen for another.

 

Inclusion Criteria
  1. Children ≥ 3 years and ≤ 18 years of age with a diagnosis of a brain tumor and who do not require sedation for MR imaging
  2. Karnofsky ≥ 70 for patients ≥ 16 years of age, and Lansky ≥ 70 for patients < 16 years of age (See Appendix 1 Performance Status Criteria)
  3. 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
  4. 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
  5. Ability to understand and the willingness of the patient, parent or legal guardian to provide informed consent

For the most up-to-date list of criteria, please visit clinicaltrials.gov.

Exclusion Criteria
  1. Patients who are not able to comply with study and/or follow-up procedures
  2. 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.
  3. Patients with history or evidence of cardiac dysfunction

For the most up-to-date list of criteria, please visit clinicaltrials.gov.

Investigator(s)

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