Pilot study of safety and feasibility of acquiring hyperpolarized imaging in patients with gliomas

Summary

Hyperpolarized ¹³C magnetic resonance metabolic imaging is a promising new technology that provides an increase in sensitivity over standard approaches of more than 10,000-fold and monitors changes in functional properties of the tumor rather than anatomic features. Pre-clinical studies indicate that ¹³C labeled pyruvate is able to cross the blood brain barrier and can be used to monitor the rate and magnitude of conversion to lactate — a molecule elevated in tumors. Having previously demonstrated this imaging technique's success in a phase I clinical trial in people with prostate cancer, the goal of this study is to translate the technology to patients with other types of tumors and to use it to study treatment effects.

Inclusion Criteria

For Patients in Cohort 1: Histologically proven glioma who have evidence of evaluable disease based on a prior MR scan.

For Patients in Cohort 2: Histologically proven glioma who will be undergoing standard treatment with radiation and temozolomide.

Additionally:

Patients must be > 18 years old and with a life expectancy > 12 weeks.
Patients must have a Karnofsky performance status of ≥ 60.
Patients must have adequate bone marrow function (WBC >3,000/μl, ANC > 1,500/mm3, platelet count of > 100,000/mm³, and hemoglobin > 10 mg/dl), adequate liver function (SGOT and bilirubin less than 1.5 times ULN), and adequate renal function (creatinine less than 1.5 mg/dL) before starting therapy. These tests must be performed within 14 days prior to Hyperpolarized Imaging scan.
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 participate inthis study or any disease that will obscure toxicity or dangerously impact response to the imaging agent.
Patients must not have New York Heart Association (NYHA) Grade II or greater congestive heart failure.
Patients must not have history of myocardial infarction or unstable angina within 12 months prior tostudy enrollment.
This study was designed to include women and minorities, but was not designed to measure differences of intervention effects. Males and females will be recruited with no preference to gender. Minorities will actively be recruited to participate. No exclusion to this study will be based on race.
Patients must sign an informed consent indicating that they are aware of the investigational nature of this study. Patients must sign an authorization for the release of their protected health information.
Patients may not be known to be HIV-positive. HIV testing is not required for study participation.
Patients must not have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off of all therapy for that disease for a minimum of 3 years.
Patients must not be pregnant or breast feeding. Women of childbearing potential are required to obtain a negative pregnancy test within 14 days of Hyperpolarized Imaging scan. Effective contraception (men and women) must be used in subjects of child-bearing potential.