Actively Recruiting

Phase Not Applicable
Age: 21Years - 90Years
All Genders
NCT02421380

Characterization of Hyperpolarized Pyruvate MRI Reproducibility

Led by Memorial Sloan Kettering Cancer Center · Updated on 2025-11-06

109

Participants Needed

2

Research Sites

574 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Characterization of Hyperpolarized Pyruvate MRI Reproducibility

Who Can Participate

Age: 21Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • History of histologically confirmed malignant solid tumor (confirmed by MSKCC Department of Pathology). An exception applies to patients with brain lesions highly suspicious for neoplasm by MRI features without histological confirmation.
  • Tumor measurable or evaluable by RECIST 1.1 or other MSKCC-approved criteria, with a mass greater than 1 cm in the long axis.
  • Negative serum or urine pregnancy test for female patients of childbearing potential within 2 weeks prior to enrollment.
  • Patients with sarcoma, prostate, breast, brain, metastatic, or pancreatic cancer are eligible. Other patient groups may be included in the future by protocol amendment.
Not Eligible

You will not qualify if you...

  • Unable or unwilling to have at least one peripheral intravenous line for pyruvate injection.
  • Breast-feeding.
  • Unable or unwilling to tolerate MRI scanning (e.g., due to claustrophobia).
  • Liver function abnormalities: bilirubin > 1.5 times upper limit of normal (ULN), AST/ALT > 2.5 times ULN, albumin < 3 g/dl, GGT > 2.5 times ULN if alkaline phosphatase > 2.5 times ULN.
  • Kidney function abnormalities: creatinine > 1.5 times ULN or creatinine clearance < 60 mL/min.
  • Acute major illness such as unstable cardiovascular conditions.
  • Standard MRI exclusions including pacemakers or metal clips in the patient.

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Trial Site Locations

Total: 2 locations

1

Memorial Sloan Kettering Bergen (Consent only )

Montvale, New Jersey, United States, 07645

Actively Recruiting

2

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

Actively Recruiting

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Research Team

K

Kayvan Keshari, PhD

CONTACT

V

Vesselin Miloushev, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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