RECRUITING

Characterization of Hyperpolarized Pyruvate MRI Reproducibility

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Characterization of Hyperpolarized Pyruvate MRI Reproducibility

Quick Facts

Study Start:2015-04
Study Completion:2025-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02421380

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * 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.
  3. * 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.
  4. * 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.
  1. * Inability or refusal to have at least one peripheral intravenous line for intravenous access (as applicable to the day of \[1-13C\] pyruvate injection)
  2. * Breast-feeding
  3. * Refusal or inability to tolerate the scanning procedure (e.g., due to claustrophobia)
  4. * 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
  5. * Bilirubin \> 1.5 x (ULN)
  6. * AST/ALT \>2.5 x ULN
  7. * Albumin \< 3 g/dl
  8. * GGT \> 2.5 x ULN if Alkaline phosphatase \> 2.5 x ULN.
  9. * Renal: Creatinine \>1.5 x ULN or creatinine clearance \< 60 mL/min, from assays obtained within 3-4 weeks prior to study enrollment
  10. * Acute major illness (e.g., unstable cardiovascular condition, etc.)
  11. * Standard MRI exclusion criteria will also be applied, including pacemakers and metal clips located in the patient.

Contacts and Locations

Study Contact

Kayvan Keshari, PhD
CONTACT
646-888-3631
Hedvig Hricak, MD, PhD
CONTACT
212-639-7284

Principal Investigator

Kayvan Keshari, PhD
PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering Bergen (Consent only )
Montvale, New Jersey, 07645
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

  • Kayvan Keshari, PhD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2015-04
Study Completion Date2025-04

Study Record Updates

Study Start Date2015-04
Study Completion Date2025-04

Terms related to this study

Keywords Provided by Researchers

  • Hyperpolarized Pyruvate
  • MRI
  • 14-205

Additional Relevant MeSH Terms

  • Malignant Solid Tumors