Determination of Pancreatic Steatosis Prevalence and Correlation With High-risk Cyst Features
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChinese University of Hong Kong
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
MRI for pancreatic fat and liver fat quantitation
Diagnostic testMR 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.
Treatment groups
236 Participants
are divided into 2 treatment groupsGroup A: Pancreatic cystic lesion subjectsActive comparator 1 intervention
Group B: Healthy subjectsActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Prevalence of pancreatic steatosis determined by fat quantitation on MRI
Prevalence of pancreatic steatosis will be determined in patients with presumed IPMN or MCN and in age and sex matched healthy subjects in the general population.
Time frame
At the time of procedureSecondary outcomes
1
Prevalence of worrisome features or high-risk stigmata on baseline EUS in patients with presumed IPMN or MCN and pancreatic steatosis
worrisome features or high-risk stigmata are defined according to 2017 revised Fukuoka international consensus guidelines
Time frame
At the time of procedure2
Prevalence of worrisome features or high-risk stigmata on baseline EUS in patients with presumed IPMN or MCN without pancreatic steatosis
worrisome features or high-risk stigmata are defined according to 2017 revised Fukuoka international consensus guidelines
Time frame
At the time of procedure3
Prevalence of coexisting fatty liver and fatty pancreas, fatty liver alone, or fatty pancreas alone in patients with presumed IPMN or MCN
Diagnosis of fatty liver, fatty pancreas will be based on fat quantitation on MRI
Time frame
At the time of procedure4
Risk factors for pancreatic steatosis in patients with presumed IPMN or MCN
Regression analysis will be used to help identify risk factors for pancreatic steatosis
Time frame
At the time of procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov