NCT02421380 · Memorial Sloan Kettering Cancer Center
Characterization of Hyperpolarized Pyruvate MRI Reproducibility
What this study 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Montvale, New Jersey
- New York, New York
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 6, 2025 · Source of record for eligibility and locations