NCT03320733Completed
Comparison Between Dual Energy/Subtraction CT With MRI for the Identification of Predictors of Malignancy in Cystic Pancreatic Lesions
Comparison of Volume-Mode 2-Rotation kV-mA Switching Dual Energy Computer Tomography (CT) and of CT Subtraction Imaging With Magnetic Resonance Imaging for the Identification of Enhancing Septa and Mural Nodules in Cystic Pancreatic Lesions
Source: ClinicalTrials.gov · Last updated 12 Mar 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 46 (actual)
- First submitted
- 19 Sept 2017
- Start date
- 1 Jul 2018
- Primary completion date
- 30 Nov 2023
- Lead sponsor
- University Health Network, Toronto
- Diseases
- Pancreatic cancer
- NCT number
- NCT03320733
What you commit to
- Study type: Interventional
- Participants enrolled: 46
- From 1 Jul 2018 to the primary completion date, 30 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- Patients younger than 40 years old or with pancreatic cysts less than 1 cm
Other
- Patients with contraindication for contrast-enhanced CT or MRI
- Pregnancy
- Patients who do not consent to the study
Who the study is looking for
- 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)
Age in the registry: 40 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Toronto, Department of Medical Imaging Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.