This phase I trial tests the safety of hyperpolarized (HP) carbon C 13 pyruvate (13C-pyruvate) magnetic resonance imaging (MRI) and how well it detects low-risk (benign) and high-risk (malignant) pancreatic cysts in patients undergoing surgical resection. Pancreatic cancer remains one of the most lethal cancers and is usually diagnosed at a later stage of the disease. Screening for pancreatic cancer is difficult with current diagnostic imaging, in part due to a high false-positive rate. 13C-pyruvate is a natural sugar found in the body which can be processed and used as an imaging agent. HP 13C-pyruvate moves through the body after injection and causes chemical reactions as the tumor's cells change the sugar into energy through a process called metabolism. The chemical reactions in the tumor cells show up in images made with MRI scans. MRI uses radiofrequency waves and a strong magnetic field to provide detailed pictures of internal organs and tissues. Using hyperppolarized 13C-pyruvate MRI (HP MR) may improve detection of malignant pancreatic cysts undergoing surgical resection.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05873699.
PRIMARY OBJECTIVE:
I. To explore the use of HP-MR in patients with cystic lesions of the pancreas undergoing surgical resection.
SECONDARY OBJECTIVES:
I. A kinetics rate constraints pyruvate to lactate (kpl) inflection point, or threshold, will then be explored to estimate the association with malignant/high risk cyst.
II. Correlate HP-MR findings to tissue metabolomics (outside the living body [ex vivo]).
III. Correlate HP-MR findings to blood and cyst fluid biomarkers.
IV. Correlate HP-MR findings to immunohistochemical staining for L-lactate dehydrogengase A chain (LDH-A) and hypoxia-inducible factor 1-alpha (HIF-1alpha).
V. Correlate gut and tissue microbiome with HP-MR findings.
VI. To explore the safety and tolerability of HP-MR in patients with cystic lesions of the pancreas undergoing surgical resection or cyst wall biopsy.
OUTLINE: Patients receive13C-pyruvate intravenously (IV) then undergo MRI for up to 30 minutes followed by standard care surgical resection or biopsy of cyst within 4 weeks on study. Patients may also undergo collection of blood serum on study.
Patients observed for at least 1 hour after administration of study drug, receive follow up phone call the following day, and monitored for toxicity for up to 30 days of imaging agent administration.
Lead OrganizationUT MD Anderson Cancer Center
Principal InvestigatorFlorencia McAllister
