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

NCT05334836 | Recruiting DMC

• 1 other identifier: 2021.636
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 1

Brief 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. 1.reduction of modifiable risk factors (eg, cigarette smoking, obesity, diabetes),
2. 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. 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.

Conditions

Pancreatic Steatosis; Pancreatic Cyst

Outcome Measures

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.

  At the time of procedure

Secondary Outcomes (4)

• Prevalence of worrisome features or high-risk stigmata on baseline EUS in patients with presumed IPMN or MCN and pancreatic steatosis

  At the time of procedure

• Prevalence of worrisome features or high-risk stigmata on baseline EUS in patients with presumed IPMN or MCN without pancreatic steatosis

  At the time of procedure

• Prevalence of coexisting fatty liver and fatty pancreas, fatty liver alone, or fatty pancreas alone in patients with presumed IPMN or MCN

  At the time of procedure

• Risk factors for pancreatic steatosis in patients with presumed IPMN or MCN

  At the time of procedure

Study Arms (2)

Pancreatic cystic lesion subjects

ACTIVE COMPARATOR

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

Diagnostic Test: MRI for pancreatic fat and liver fat quantitation

Healthy subjects

ACTIVE COMPARATOR

Healthy subjects

Diagnostic Test: MRI for pancreatic fat and liver fat quantitation

Interventions

MRI for pancreatic fat and liver fat quantitation DIAGNOSTIC_TEST

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.

Healthy subjects; Pancreatic cystic lesion subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital, The Chinese University of Hong Kong

Shatin, New Territories, Hong Kong

RECRUITING

MeSH Terms

Conditions

Pancreatic Cyst

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Raymond S Tang, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Felix Sia

CONTACT

26370428; felixsia@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assitant Professor

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: April 19, 2022
• Study Start: April 6, 2022
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)