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CompletedNCT03320733Updated Mar 12, 2024

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

An interventional study of Dual energy CT scan with subtraction imaging in Pancreatic Cyst, sponsored by University Health Network, Toronto. Completed at 1 site in Canada. Open to participants aged 40 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-03-12.

Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Non-randomized
Ages
40 Years to 100 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Pancreatic Cyst

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Keywords

  • dual energy CT
03

In context

Pancreatic Cyst

97 studies on the registry are indexed under Pancreatic Cyst; 37 are open to participants now.

This study's enrollment of 46 is below the median of 84 across 38 interventional studies indexed under Pancreatic Cyst.

Browse Pancreatic Cyst studies →

Lead sponsor

University Health Network, Toronto is the lead sponsor of 1,438 studies on the registry; 297 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion criteria:

  • Patients with 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
46 participants (actual)

Study arms

  • Experimental
    Surgical

    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

  • Experimental
    Surveillance

    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

  • Diagnostic testDual energy CT scan with subtraction imaging

    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.

06

What researchers measure

Primary outcomes

  1. Sensitivity

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

    Time frame: 2 years

  2. Specificity

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

    Time frame: 2 years

  3. Positive predicative value

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

    Time frame: 2 years

  4. Negative predicative value

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

    Time frame: 2 years

Secondary outcomes

  1. Parameters optimization HU

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

    Time frame: 2 years

  2. Parameters optimization keV

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

    Time frame: 2 years

07

Study locations

1 site
  • University of Toronto, Department of Medical Imaging
    Toronto, Ontario M5G 2N2, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2018 to primary completion in Nov 2023, 64 months.

Of 17 interventional studies with no phase under Pancreatic Cyst, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 64. This study's 64 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 19, 2017
First posted
Oct 25, 2017
StartActual
Jul 1, 2018
Primary completionActual
Nov 30, 2023
CompletionActual
Nov 30, 2023
Last update
Mar 12, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03320733
Responsible party
Sponsor
First posted
Oct 25, 2017
Start date
Jul 1, 2018
Primary completion
Nov 30, 2023
Completion
Nov 30, 2023
Last update
Mar 12, 2024

Study contacts

Luis Guimaraes, MD
principal investigator · University of Toronto, Department of Medical Imaging

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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