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.
Additional locations may be listed on ClinicalTrials.gov for NCT05873699.
See trial information on ClinicalTrials.gov for a list of participating sites.
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 OrganizationM D Anderson Cancer Center
Principal InvestigatorFlorencia McAllister
