Characterization of Hyperpolarized Pyruvate MRI Reproducibility

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.

Study Overview

• Status: Recruiting
• Conditions: Malignant Solid Tumors
• Intervention / Treatment: Drug: Hyperpolarized Pyruvate

• Study Type: Interventional
• Enrollment (Estimated): 109
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kayvan Keshari, PhD; Phone Number: 646-888-3631
• Study Contact Backup: Name: Hedvig Hricak, MD, PhD; Phone Number: 212-639-7284

Study Locations

• United States
  • New Jersey
    • Montvale, New Jersey, United States, 07645
      • Recruiting
      • Memorial Sloan Kettering Bergen (Consent Only )
      • Contact: Kayvan Keshari, PhD; Phone Number: 646-888-3631
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center
      • Contact: Kayvan Keshari, PhD; Phone Number: 646-888-3631
      • Contact: Hedvig Hricak, MD, PhD; Phone Number: 212-639-7284

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hyperpolarized Pyruvate MRI Reproducibility; 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.	Drug: Hyperpolarized Pyruvate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
validate HP MRI at MSKCC (are the scans able to be reproduced)	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.	1 year

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Kayvan Keshari, PhD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

General Publications

• Granlund KL, Tee SS, Vargas HA, Lyashchenko SK, Reznik E, Fine S, Laudone V, Eastham JA, Touijer KA, Reuter VE, Gonen M, Sosa RE, Nicholson D, Guo YW, Chen AP, Tropp J, Robb F, Hricak H, Keshari KR. Hyperpolarized MRI of Human Prostate Cancer Reveals Increased Lactate with Tumor Grade Driven by Monocarboxylate Transporter 1. Cell Metab. 2020 Jan 7;31(1):105-114.e3. doi: 10.1016/j.cmet.2019.08.024. Epub 2019 Sep 26.

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: April 13, 2015
• First Submitted That Met QC Criteria: April 17, 2015
• First Posted (Estimated): April 20, 2015

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 30, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: MRI; Hyperpolarized Pyruvate; 14-205
• Other Study ID Numbers: 14-205