Testing a new MRI method for solid tumors
Official title: Characterization of Hyperpolarized Pyruvate MRI Reproducibility
Run by Memorial Sloan Kettering Cancer Center · NCT02421380 · Data updated 2026-11-12
This study is testing a new MRI method using hyperpolarized pyruvate to see if it can give consistent results about the metabolism of different solid tumors in patients.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 21 Years to 90 Years |
| Sex | All |
| Enrollment | 109 (estimated) |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Locations | 2 sites (Montvale, New Jersey and 1 other locations) |
| Status | Recruiting |
| Started | April 2015 |
| Main results expected | April 2027 |
| Study ends | April 2027 |
| Registry record updated | July 21, 2026 |
| Trial ID | NCT02421380 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients with histologically-confirmed malignant solid tumors or those with brain lesions suspected of being neoplastic.
✕Probably not a fit
Patients without measurable or evaluable tumors or those not meeting the inclusion criteria may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the reproducibility of hyperpolarized pyruvate MRI scans in patients with malignant solid tumors. Participants will undergo two MRI scans using hyperpolarized pyruvate to determine if the results can be consistently reproduced. The findings from these scans will be compared to pathological results obtained from surgery to assess the additional insights provided by this imaging technique regarding tumor metabolism. The study focuses on various types of solid tumors, including sarcoma, prostate, breast, brain, metastatic, and pancreatic cancers.
Why it matters
Potential benefit: If successful, this approach could enhance the accuracy of tumor assessments and improve treatment planning for patients with solid tumors.
How similar studies have gone: While the use of hyperpolarized MRI is a novel approach, similar imaging techniques have shown promise in other studies, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion 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.) * Standard MRI exclusion criteria will also be applied, including pacemakers and metal clips located in the patient.
Where it's running
-
Memorial Sloan Kettering Bergen (Consent only )
Montvale, New Jersey, United States Recruiting -
Memorial Sloan Kettering Cancer Center
New York, New York, United States Recruiting
Study contacts
- Principal investigator: Kayvan Keshari, PhD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Kayvan Keshari, PhD
- Phone: 646-888-3631
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.