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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05334836
Other study ID # 2021.636
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 6, 2022
Est. completion date December 30, 2025

Study information

Verified date April 2023
Source Chinese University of Hong Kong
Contact Felix Sia
Phone 26370428
Email felixsia@cuhk.edu.hk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
MRI 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.

Locations

Country Name City State
Hong Kong Prince of Wales Hospital, The Chinese University of Hong Kong Sha Tin New Territories

Sponsors (1)

Lead Sponsor Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. At the time of procedure
Secondary 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 At the time of procedure
Secondary 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 At the time of procedure
Secondary 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 At the time of procedure
Secondary 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 At the time of procedure
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