Comparison Between Dual Energy/Subtraction CT With MRI for the Identification of Predictors of Malignancy in Cystic Pancreatic Lesions

NCT03320733 | Completed

• 1 other identifier: 17-5314.0
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

Cystic pancreatic lesions are increasingly detected incidentally in imaging studies, reportedly in up to 45% of the abdominal Magnetic Resonance (MR) examinations. The majority of these lesions have potential to become cancer, therefore requiring surgery or imaging follow-up to monitor the development of features indicative of malignant transformation. Abdominal MR is the current standard of care for the follow-up of pancreatic cysts (PCs). However, MR is expensive and access is limited, In our institution, more than 35 MR studies for assessment of PCs were performed each month in 2015, placing a significant burden on the health care system that includes contributing to longer MR wait times for other indications. The investigators will compare MR to two new computed tomography (CT) techniques - dual energy CT (DECT) and Subtraction imaging - with regards to their ability to detect features associated with increased risk of malignancy (enhancing septa and mural nodules) in PCs. For cases where there is disagreement between these 2 CT techniques and MR, histopathology of the surgical specimen or the results of Endoscopic Ultrasound (EUS) will serve as reference standard. Using DECT or Subtraction instead of MR for the assessment and follow-up of PCs would save significant healthcare costs and MR slots, which could be released to other indications and to reduce waiting times. Furthermore, if DECT and/or Subtraction imaging end up demonstrating to be superior to MR for this purpose, patients with cystic pancreatic lesions could have a direct benefit.

Conditions

Pancreatic Cyst

Keywords

dual energy CT

Outcome Measures

Primary Outcomes (4)

• Sensitivity

  Sensitivity of Dual Energy CT in prediction of malignancy for pancreatic cysts \> 1cm.

  2 years

• Specificity

  Specificity of Dual Energy CT in prediction of malignancy for pancreatic cysts \> 1cm.

  2 years

• Positive predicative value

  Positive predicative value (PPV) of Dual Energy CT in prediction of malignancy for pancreatic cysts \> 1cm.

  2 years

• Negative predicative value

  Negative predicative value (NPV) of Dual Energy CT in prediction of malignancy for pancreatic cysts \> 1cm.

  2 years

Secondary Outcomes (2)

• Parameters optimization HU

  2 years

• Parameters optimization keV

  2 years

Study Arms (2)

Surgical

EXPERIMENTAL

Includes patients who will undergo surgery for their pancreatic cysts. In addition to the routine pre-operative CT abdomen performed for surgical planning purposes, these patients will receive Dual Energy CT scan with subtraction imaging before surgery.

Diagnostic Test: Dual energy CT scan with subtraction imaging

Surveillance

EXPERIMENTAL

Includes patients who are undergoing surveillance for their pancreatic cysts. Dual Energy CT scan with subtraction imaging will be performed in addition to the standard-of-care surveillance method of MRI scans.

Diagnostic Test: Dual energy CT scan with subtraction imaging

Interventions

Dual energy CT scan with subtraction imaging DIAGNOSTIC_TEST

The single source V2R kmAS dual energy CT system has several theoretical advantages compared, such as perfectly matched X-ray paths and the possibility of performing dual-energy processing using projection data. Subtraction imaging is an accurate deformable registration algorithm that allows creation of iodine maps from matched pre- and post-contrast acquisitions. This algorithm can be applied to both single and dual energy CT.

Surgical; Surveillance

Eligibility Criteria

• Age: 40 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of all ethnic groups older than 40 years old
• Cystic pancreatic lesions larger than 1 cm documented by MR
• Scheduled for surgery (Group 1) or undergoing surveillance (Group 2) for a pancreatic cyst by a hepatobiliary surgeon at UHN (University Health Network)

You may not qualify if:

• Patients with contraindication for contrast-enhanced CT or MRI
• Pregnancy
• Patients who do not consent to the study
• Patients younger than 40 years old or with pancreatic cysts less than 1 cm

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University of Toronto, Department of Medical Imaging

Toronto, Ontario, M5G 2N2, Canada

Location

MeSH Terms

Conditions

Pancreatic Cyst

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Pancreatic Diseases; Digestive System Diseases

Study Officials

• Luis Guimaraes, MD

  University of Toronto, Department of Medical Imaging

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2017
• First Posted: October 25, 2017
• Study Start: July 1, 2018
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)