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Pyruvate

This is a reproducibility study of hyperpolarized \[1-13C\] pyruvate MRI in patients with solid tumors. A total of 100 patients will be enrolled, 50 of whom will be imaged using 1D MR spectroscopy and the other 50 with 3D imaging sequence.

Hyperpolarized Pyruvate

Kayvan Keshari, PhD

Hedvig Hricak, MD, PhD

The purpose of the study is to test a new approach to see if the test results can be reproduced each time the Magnetic resonance imaging (MRI) is done for an individual patient. The study will explore the use of an imaging agent called hyperpolarized \[1-13C\] pyruvate (HP) with MRI scans. (MRI) is a technique that takes pictures of the body's organs using a magnetic field and radiofrequency waves that cannot be felt. In order to accomplish the goal of the study the patient will have two hyperpolarized MRI scans to assess if scans can be reproduced. The hyperpolarized MRI scans will be compared with the pathological results of the surgery to see if the hyperpolarized MRI provides additional information regarding disease metabolism.

Characterization of Hyperpolarized Pyruvate MRI Reproducibility

The imaging will include standard T2-weighted, diffusion-weighted (DW), dynamic contrast-enhanced (DCE) and 1H MR spectroscopic imaging, depending on the solid tumor type. This multi-parametric data will be used to delineate the tumor as well as compare to HP MRI.

Memorial Sloan Kettering Cancer Center

Neoplasms

Nervous System Diseases

All Conditions

Rare Diseases

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Brain Tumor, Childhood

Patients will receive a one-time injection of Hyperpolarized Pyruvate prior to a single MR imaging examination that includes the acquisition of HP carbon-13 metabolic data.

Sabine Mueller, MD, PhD, MAS

This is a single arm pilot trial within the Pacific Pediatric Neuro-Oncology Consortium (PNOC).

The pilot study will look at the 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.

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

PNOC 011: Pilot Study of Safety and Toxicity of Acquiring Hyperpolarized Carbon-13 Imaging in Children With Brain Tumors

Dose Limiting Toxicities will be assessed by monitoring for adverse events, scheduled laboratory assessments, vital sign measurements, ECGs, and physical examinations. The severity of the toxicities will be graded according to the NCI CTCAE v4.0. Adverse events and clinically significant laboratory abnormalities will be summarized by maximum intensity and relationship to study drug. Safety will be assessed during the infusion and at least for one hour after completion of the infusion as well as by phone 24 hours after the infusion. Descriptive statistics will be utilized to display the data on toxicity seen. Analyses will be performed for all patients having received at least one dose of study drug.

13C data will be acquired using the following sequence parameters;

* a volumetric acquisition from a 4-5cm slice with 2D phase encoding and 1-D Echo-Planar Spectroscopic Imaging (EPSI) encoding, field of view (FOV) 20x24x10cm (1cc voxel size),
* 1H scout; A further set of scout images will be obtained to re-establish appropriate landmarks.
* High resolution anatomic imaging: These require a 3D localizing scan to define the graphical prescription;
* Diffusion Images: This will be followed by diffusion tensor spin echo single shot echo planar images, 6 gradient directions, 22cm FOV, 128x128 matrix,
* Lactate edited 3D magnetic resonance spectroscopic imaging (MRSI): water suppressed 1H magnetic resonance spectroscopy (MRS) with PRESS volume selection, out-of-voxel suppression with very spatially selective rf pulses, echo planar encoding in the signal intensity (SI) direction and 2D in-plane phase encoding

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Characterization of Hyperpolarized Pyruvate MRI Reproducibility	NCT02421380	Malignant Solid...	Hyperpolarized ...	21 Years - 90 Years	Memorial Sloan Kettering Cancer Center
Characterization of Hyperpolarized Pyruvate MRI Reproducibility	NCT02421380	Malignant Solid...	Hyperpolarized ...	21 Years - 90 Years	Memorial Sloan Kettering Cancer Center
Characterization of Hyperpolarized Pyruvate MRI Reproducibility	NCT02421380	Malignant Solid...	Hyperpolarized ...	21 Years - 90 Years	Memorial Sloan Kettering Cancer Center
Pilot Study of Safety and Toxicity of Acquiring Hyperpolarized Carbon-13 Imaging in Children With Brain Tumors	NCT02947373	Pediatric Brain...	Hyperpolarized ...	3 Years - 18 Years	University of California, San Francisco

Spots Global Cancer Trial Database for hyperpolarized pyruvate