Characterization of Hyperpolarized Pyruvate MRI Reproducibility
1 other identifier
interventional
109
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2015
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 13, 2015
CompletedFirst Posted
Study publicly available on registry
April 20, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2026
CompletedNovember 6, 2025
November 1, 2025
11 years
April 13, 2015
November 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Hyperpolarized Pyruvate MRI Reproducibility
EXPERIMENTALThis 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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Memorial Sloan Kettering Bergen (Consent only )
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Related Publications (1)
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.
PMID: 31564440DERIVED
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Kayvan Keshari, PhD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2015
First Posted
April 20, 2015
Study Start
April 1, 2015
Primary Completion
April 1, 2026
Study Completion
April 1, 2026
Last Updated
November 6, 2025
Record last verified: 2025-11