RECRUITING

Hyperpolarized C Pyruvate Magnetic Resonance Imaging, and Blood-Based Biomarkers for Early Detection of Pancreatic Adenocarcinoma in Patients with Intraductal Papillary Mucinous Neoplasms

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 this study is for researchers to find ways of detecting pancreatic ductal adenocarcinoma/PDAC early to avoid the invasive procedure of surgery. The study researchers think a combination of imaging and a series of blood tests may be an effective way to detect PDAC early. In this study, researchers will look at whether a combination of the following types of imaging with blood tests can detect PDAC in pancreatic cysts: * The ImmunoPET scan (immune-positron emission tomography scan) with the imaging agent 89Zr-DFO-HuMab-5B1 * The HP MRI scan (hyperpolarized pyruvate magnetic resonance imaging scan)

Official Title

Immuno-Positron Emission Tomography, Hyperpolarized C Pyruvate Magnetic Resonance Imaging, and Blood-Based Biomarkers for Early Detection of Pancreatic Adenocarcinoma in Patients with Intraductal Papillary Mucinous Neoplasms

Quick Facts

Study Start:2024-03-04
Study Completion:2030-03-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06305728

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:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Men and women aged \>18 years
  2. * Pancreatic cystic neoplasm deemed to be high risk and requiring surgical resection
  3. * Able to provide informed consent
  1. * Pathologic evidence of pancreatic cancer
  2. * Pregnant or breast-feeding patients
  3. * Refusal or inability to tolerate scan (eg anxiety or claustrophobia)
  4. * Inability to lay flat or meet the standard requirements of traditional MRI
  5. * Hepatic function from assays obtained within 6 weeks prior to the 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
  6. 1. Bilirubin \> 1.5 x ULN
  7. 2. AST/ALT \> 2.5 x ULN
  8. 3. Albumin \< 3 g/dL
  9. 4. GGT \> 2.5 x ULN if Alkaline Phosphatase \> 2.5 x ULN
  10. * Renal function with Creatinine \> 1.5 x ULN or creatinine clearance \< 60 mL/min, from assays obtained within 6 weeks prior to study enrollment
  11. * Cardiac: congestive heart failure with New York Heart Association (NYHA) status ≥2, poorly controlled hypertension, a history of clinically significant EKG abnormalities, or myocardial infarction within 6 months of study enrollment.

Contacts and Locations

Study Contact

Kevin Soares, MD
CONTACT
212-639-3195
soaresk@mskcc.org
David Kelson, MD
CONTACT
646-888-4179
kelsend@MSKCC.ORG

Principal Investigator

Kevin Soares, MD
PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
United States
Memorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown, New Jersey, 07748
United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
United States
Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)
Commack, New York, 11725
United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
United States
Memorial Sloan Kettering Cancer Center (All protocol activites)
New York, New York, 10065
United States
Weill Cornell Medical Center (Specimen Analysis Only)
New York, New York, 10065
United States
Memorial Sloan Kettering Nassau (Limited Protocol Activites)
Rockville Centre, New York, 11553
United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

  • Kevin Soares, MD, 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 Date2024-03-04
Study Completion Date2030-03-04

Study Record Updates

Study Start Date2024-03-04
Study Completion Date2030-03-04

Terms related to this study

Keywords Provided by Researchers

  • Pancreatic Cyst
  • Memorial Sloan Kettering Cancer Center
  • 23-367

Additional Relevant MeSH Terms

  • Pancreatic Cyst