Characterization of Hyperpolarized Pyruvate MRI Reproducibility
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 21 - 90 |
| Updated: | 1/19/2019 |
| Start Date: | April 2015 |
| End Date: | April 2019 |
| Contact: | Kayvan Keshari, PhD |
| Phone: | 646-888-3631 |
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.
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.
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 or
metastatic 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 <2 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
<2 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.
We found this trial at
1
site
1275 York Ave
New York, New York 10021
New York, New York 10021
(212) 639-2000
Phone: 646-888-3631
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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