Characterization of Hyperpolarized Pyruvate MRI Reproducibility

Recruitment & Eligibility

Inclusion Criteria

Patients with history of histologically-confirmed malignant solid tumor (histology confirmed by MSKCC Department of Pathology.) NOTE: An exception will be made for patients with brain lesions. Patients identified by a radiologist to have a brain lesion with high suspicion for neoplasm given MRI features will be enrolled, prior to histological confirmation.
Disease measurable or evaluable as defined by RECIST 1.1, a mass of greater than 1cm in the long axis and/or other tumor response criteria from an MSKCC IRB-approved clinical research protocol. NOTE: Study patients do not need to be participating in an MSKCC approved clinical trial prior to study recruitment.
Negative serum or urine pregnancy test for female patients of childbearing age and potential (as defined by MSKCC Standards & Guidelines), from assays obtained < 2 weeks prior to study enrollment.
This study will include only patients with sarcoma, prostate, breast, brain, metastatic or pancreatic cancer. In the future other patient groups may be included through amendment of this protocol.

Exclusion Criteria

Inability or refusal to have at least one peripheral intravenous line for intravenous access (as applicable to the day of [1-13C] pyruvate injection)
Breast-feeding
Refusal or inability to tolerate the scanning procedure (e.g., due to claustrophobia)
Hepatic: from assays obtained within 3-4 weeks prior to study enrollment. For each patient, the upper limit of normal (ULN) value for a particular assay will be defined by the normal reference values of the laboratory that performed the assay
Bilirubin > 1.5 x (ULN)
AST/ALT >2.5 x ULN
Albumin < 3 g/dl
GGT > 2.5 x ULN if Alkaline phosphatase > 2.5 x ULN.
Renal: Creatinine >1.5 x ULN or creatinine clearance < 60 mL/min, from assays obtained within 3-4 weeks prior to study enrollment
Acute major illness (e.g., unstable cardiovascular condition, etc.)
Standard MRI exclusion criteria will also be applied, including pacemakers and metal clips located in the patient.

Study & Design

Arm && Interventions

Group	Intervention	Description
Hyperpolarized Pyruvate MRI Reproducibility	Hyperpolarized 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.

Primary Outcome Measures

Name	Time	Method
validate HP MRI at MSKCC (are the scans able to be reproduced)	1 year	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.

Secondary Outcome Measures

Name	Time	Method

Recruitment & Eligibility