RecruitingNot ApplicableNCT05334836

Determination of Pancreatic Steatosis Prevalence and Correlation With High-risk Cyst Features

Determination of Pancreatic Steatosis Prevalence and Correlation With High-risk Cyst Features in Patients With Pre-malignant Pancreatic Cystic Neoplasms Using Magnetic Resonance Imaging and Endoscopic Ultrasound

Sponsor

Chinese University of Hong Kong

Enrollment

236 participants

Start Date

Apr 6, 2022

Study Type

INTERVENTIONAL

Conditions

Pancreatic Cyst Pancreatic Steatosis

Summary

Pancreatic cancer is the fifth leading cause of cancer mortality in Hong Kong and the seventh leading cause of cancer mortality worldwide. In 2020, approximately 496000 new cases of pancreatic cancers were diagnosed globally . Pancreatic cancer is a highly fatal cancer with a case-fatality rate of 94.0% globally. In Hong Kong, both the incidence and mortality of pancreatic cancer have increased over the past decade. Due to the deep-seated location of pancreas, it is difficult to diagnose pancreatic cancer at an early stage, which in turn leads to delays in cancer treatment and poorer survival. Despite advances in oncologic treatment, the 5-year survival rate of metastatic pancreatic cancer remains poor (\~2.9%). As such, there has been growing interest to improve pancreatic cancer prevention and survival by: 1. reduction of modifiable risk factors (eg, cigarette smoking, obesity, diabetes), 2. screening for early detection of high-risk pre-malignant lesions in selected high-risks patients with strong family history of pancreatic cancer and/or certain germline mutations of pancreatic cancer susceptibility genes (eg, BRCA1, BRAC2, DNA mismatch repair genes in Lynch Syndrome, etc) by magnetic resonance imaging (MRI) or endoscopic ultrasound (EUS), and 3. surveillance of pre-malignant precursor lesions such as mucinous pancreatic cystic neoplasms (PCN) by imaging and/or EUS to identify high-risk neoplastic progression indicated for surgical resection.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

Age 18 or older
Patients with at least 1 pancreatic cystic lesion presumed to be IPMN or MCN based on CT, MRI or EUS features, with a cyst size ≥ 5mm; or healthy subjects.
Patients who are able to provide written informed consent to participate in the study and comply with the study procedures.

Exclusion Criteria5

Unable to provide written informed consent
Patients with metallic implants or other contraindications to MRI
Patients with contraindications for endoscopy due to comorbidities
Patients with known pancreatic cancer or prior pancreatic resection
Patients with significant alcohol consumption, defined as alcohol intake of over 20 g daily (140 g weekly) for men and 10 g daily (70 g weekly) for women

Interventions

DIAGNOSTIC_TESTMRI for pancreatic fat and liver fat quantitation

MR imaging would be performed using a 3.0 T scanner (Achieva X series, Philips Healthcare, Best, The Netherlands) with a 16-channel SENSE-XL-Torso array coil. 3D spoiled chemical-shift water-fat mDixon sequence (TR = 5.7 ms, first TE/echo spacing = 1.2-1.4 (ms)/1.0-1.2 (ms), number of echoes = 6, flip angle = 3°, SENSE acceleration = 2, a breath hold technique would be employed to acquire co-registered water, fat, fat-fraction and T2\* image series and would be reconstructed with slice thickness/number of slices = 3.0 mm/50. The field of view (FOV) covered the upper abdomen, i.e. region from the dome of the diaphragm to the iliac crest covering the entire extent of the liver and pancreas. Image reconstruction would be completed online using Philips mDixon product implementation with the multi-peak spectral model of fat to increase accuracy and sensitivity.