Characterization of Hyperpolarized Pyruvate MRI Reproducibility

Malignant Solid Tumors Clinical Trial

Official title:

Characterization of Hyperpolarized Pyruvate MRI Reproducibility

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02421380
• Other study ID #: 14-205
• Status: Recruiting
• Phase: N/A
• Start date: April 2015
• Est. completion date: April 2025

Study information

• Verified date: October 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Kayvan Keshari, PhD
• Phone: 646-888-3631
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 109
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Malignant Solid Tumors

Intervention

Drug:
• Hyperpolarized Pyruvate

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Bergen (Consent only )	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Memorial Sloan Kettering Cancer Center