Characterization of Hyperpolarized Pyruvate MRI Reproducibility

NCT ID: NCT02421380

Last Updated: 2025-11-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 109 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2026-04-30

Brief Summary

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.

Conditions

Malignant Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Hyperpolarized Pyruvate

Intervention Type: DRUG

Interventions

Hyperpolarized Pyruvate

Intervention Type: DRUG

Eligibility Criteria

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.)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kayvan Keshari, PhD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Bergen (Consent only )

Montvale, New Jersey, United States

Site Status: RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kayvan Keshari, PhD

Role: CONTACT

646-888-3631

Vesselin Miloushev, MD

Role: CONTACT

miloushv@mskcc.org

212-639-3087

Facility Contacts

Kayvan Keshari, PhD

Role: primary

646-888-3631

Kayvan Keshari, PhD

Role: primary

646-888-3631

Vesselin Miloushev, MD

Role: backup

212-639-3087

References

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.

Reference Type: DERIVED

PMID: 31564440 (View on PubMed)

Related Links

http://www.mskcc.org/

Memorial Sloan Kettering Cancer Center

Other Identifiers

14-205

Identifier Type: -

Identifier Source: org_study_id