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.
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
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. 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.
Sensitivity
Sensitivity of Dual Energy CT in prediction of malignancy for pancreatic cysts > 1cm.
Measured: 2 years
Specificity
Specificity of Dual Energy CT in prediction of malignancy for pancreatic cysts > 1cm.
Measured: 2 years
Positive predicative value
Positive predicative value (PPV) of Dual Energy CT in prediction of malignancy for pancreatic cysts > 1cm.
Measured: 2 years
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)
Parameters optimization HU
Cutoffs of Hounsfield Units (HU) on Subtraction imaging for true enhancing components of pancreatic cysts.
Measured: 2 years
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.
- First posted25 Oct 2017
- Study start1 Jul 2018
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CystStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luis Guimaraes, MD, Principal investigator, University of Toronto, Department of Medical Imaging
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03320733
- Acronym / sponsor ID
- 17-5314.0
- Conditions
- Pancreatic Cyst
- Keywords
- dual energy CT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 25 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical | Experimental | Diagnostic Test: Dual energy CT scan with subtraction imagingIncludes 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. |
| Surveillance | Experimental | Diagnostic Test: Dual energy CT scan with subtraction imagingIncludes 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. |
Who may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dual energy CT scan with subtraction imagingThe 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. | Diagnostic test | Surgical, Surveillance |
Primary outcome
Sensitivity
Time frame: 2 years
Sensitivity of Dual Energy CT in prediction of malignancy for pancreatic cysts > 1cm.
Specificity
Time frame: 2 years
Specificity of Dual Energy CT in prediction of malignancy for pancreatic cysts > 1cm.
Positive predicative value
Time frame: 2 years
Positive predicative value (PPV) of Dual Energy CT in prediction of malignancy for pancreatic cysts > 1cm.
Negative predicative value
Time frame: 2 years
Negative predicative value (NPV) of Dual Energy CT in prediction of malignancy for pancreatic cysts > 1cm.
2 secondary outcomes
Parameters optimization HU
Time frame: 2 years
Parameters optimization keV
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis Guimaraes, MD principal investigator
University of Toronto, Department of Medical Imaging
1 site in 1 country: see every site and its status.
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.