Characterization of Hyperpolarized Pyruvate MRI Reproducibility

  • STATUS
    Recruiting
  • End date
    Apr 18, 2024
  • participants needed
    109
  • sponsor
    Memorial Sloan Kettering Cancer Center
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Updated on 4 October 2022
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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.

Details
Condition Malignant Solid Tumors
Treatment Hyperpolarized Pyruvate
Clinical Study IdentifierNCT02421380
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on4 October 2022

Eligibility

 Yes No Not Sure

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
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