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Pancreatic CystNCT03320733

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

A study testing Dual energy CT scan with subtraction imaging in people with Pancreatic Cyst, run by University Health Network, Toronto at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 40 to 100 years
Conditions the study is for
Pancreatic Cyst
What is being tested?
Dual energy CT scan with subtraction imaging
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteCanada
Study dates
1 Jul 2018to 30 Nov 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • University of Toronto, Department of Medical Imaging

    Toronto, Ontario, M5G 2N2

Other trials in Canada

About this study

Official title: 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

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.

Read the detailed description

With the rapid technological advancement, growth and widespread use of cross-sectional imaging, there has been increased detection of pancreatic cystic lesions (PCs). The reported incidence of pancreatic cysts varies widely, with some studies reporting incidental pancreatic cysts detected in 0.7-2.6 % of asymptomatic adults undergoing imaging. The incidence reportedly increases with age with a greater than 8% detection rate in those over age 80 years. The prevalence of a cystic pancreatic lesion in one autopsy series was as high as 24%. For MRI, the frequency of detection of a pancreatic cyst is significantly higher than that of CT, with a reported prevalence of 13-45 % for MRI. Consequently, there has been a significant increased number of MRs ordered for follow-up of these lesions. In our institution, more than 35 MR studies for assessment of PCs were performed each month in 2015. This represents greater than 5% of all abdominal/pelvic MR examinations, and this number appears to be growing. The impact on health care system - particularly on health care costs as well as MR waiting times for patients with other conditions - is significant. For instance, in our institution, the average waiting period in 2015 for an outpatient MR enterography for patients with Crohn's disease is over 6 months.

Recently, dual energy CT (DECT) has proven to be robust and clinically useful for many abdominal applications (including solid pancreatic masses). The investigators expect V2R kVmAS DECT and Subtraction imaging - two promising techniques which have scarcely been investigated in abdominal disease processes in the literature - to prove to be very useful for the characterization of pancreatic cysts and to demonstrate comparable diagnostic accuracy compared to MR

The aim of the study is to investigate whether optimized DECT and/or Subtraction imaging protocols allow for characterization of cystic pancreatic lesions (in particular, the presence of enhancing septa and mural nodules) with a diagnostic accuracy equivalent to or greater than MRI.

This is a prospective, single-institution study in patients who are being evaluated or followed for known pancreatic cystic lesions who are planned for a CT and MRI scan. All MRI scans performed during the study period will be monitored prospectively to identify consecutive patients undergoing MRI for assessment or follow-up of pancreatic cystic lesions and meeting the study inclusion/exclusion criteria.

Patients will be divided into two groups:

  • Group 1 includes patients who will undergo surgery for their pancreatic cysts: For these patients, a pre-operative CT abdomen is routinely performed for surgical planning purposes. The treating surgeon will contact the study team to arrange for the CT scan - which will include a DECT scan - to be performed on the appropriate scanner.
  • Group 2 includes patients who are undergoing surveillance. For these patients, the standard of care is typically to follow these patients annually with serial MRI scans.

In cases where findings on MRI are in doubt, a CT scan - which will include a DECT scan - will be requested as a problem solving tool and part of the standard of care.

For most patients, a CT scan is not required as part of the standard of care. In these cases, patients will be recruited and consented for an additional CT scan - which will include a DECT scan - to be performed within 6 months of their MRI. This CT scan is in addition to the standard of care. The patient will be recruited at the time of the first follow-up appointment with their treating surgeon after their MRI scan.

Conditions
Pancreatic Cyst
Being tested
Dual energy CT scan with subtraction imaging
Keywords
dual energy CT
Medical subject headings
Pancreatic Cyst

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dual energy CT scan with subtraction imagingDiagnostic 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.

Study groups in NCT03320733
Study groupRoleWhat they receive
SurgicalExperimentalIncludes 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.
Receives: Diagnostic Test: Dual energy CT scan with subtraction imaging
SurveillanceExperimentalIncludes 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.
Receives: Diagnostic Test: Dual energy CT scan with subtraction imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sensitivity

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

    Measured: 2 years

  2. Specificity

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

    Measured: 2 years

  3. Positive predicative value

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

    Measured: 2 years

  4. Negative predicative value

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

    Measured: 2 years

Secondary outcomes (2)
  1. Parameters optimization HU

    Cutoffs of Hounsfield Units (HU) on Subtraction imaging for true enhancing components of pancreatic cysts.

    Measured: 2 years

  2. Parameters optimization keV

    Optimal keV value on virtual monochromatic DECT images for true enhancing components of pancreatic cysts.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2017
  2. Study start1 Jul 2018
  3. Primary completion30 Nov 2023
  4. Study completion30 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03320733
Sponsor's protocol ID
17-5314.0
Status last verified
Mar 2024
First submitted
19 Sep 2017
Last updated
12 Mar 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Dual energy CT scan with subtraction imaging in people with Pancreatic Cyst, run by University Health Network, Toronto at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensitivity (time frame: 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.

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