Recruiting

Hyperpolarized Pyruvate

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT02421380

Conditions

Malignant Solid Tumors

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

Hyperpolarized Pyruvate

Study Details

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 ID

NCT02421380

Start date

Apr, 2015

Status verified date

Jul, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

109 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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.

Interventions

Hyperpolarized Pyruvate

Primary outcome measure

  • validate HP MRI at MSKCC (are the scans able to be reproduced) [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Kayvan Keshari, PhD

646-888-3631

Vesselin Miloushev, MD

212-639-3087miloushv@mskcc.org

Locations

Memorial Sloan Kettering Bergen (Consent only )

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Kayvan Keshari, PhD

646-888-3631

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Kayvan Keshari, PhD

646-888-3631

Vesselin Miloushev, MD

212-639-3087

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Jul 21, 2026

Last verified

Jul, 2026

Keywords

  • Hyperpolarized Pyruvate
  • MRI
  • 14-205

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-07-21.