Pancreas CystNCT03731819
Establishment of Abbreviated Pancreatobiliary MRI Protocol
A study testing Abbreviated PB MRI in people with Pancreas Cyst and Intraductal Papillary Mucinous Neoplasm, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study aims to establish abbreviated PB MRI protocol for patients on regular imaging follow-up for pancreas cystic neoplasm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Cyst, Intraductal Papillary Mucinous Neoplasm
- What is being tested?
- Abbreviated PB MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Nov 2018to 4 May 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- on follow-up for pancreas intraductal mucinous neoplasm
- OR incidentally detected pancreas cyst (equal to or larger than 1cm)
- AND scheduled for CECT or has CECT within a months
- AND sign informed consent
Who cannot join
- Any absolute or relative contra-indication for contrast-enhanced MRI
- No pancreas cystic neoplasm
- History of pancreatectomy
- History of any procedure for pancreatic cyst (ablation, aspiration...) in a year
- Hemosiderosis
- Suspicion of acute pancreatitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Establishment of Abbreviated Pancreatobiliary MRI Using Compressed Sensing Technique for Pancreas Cystic Neoplasm Follow-up
This study aims to establish abbreviated PB MRI protocol for patients on regular imaging follow-up for pancreas cystic neoplasm.
- Being tested
- Abbreviated PB MRI
- Keywords
- MRI
- Medical subject headings
- Pancreatic Cyst
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abbreviated PB MRIDiagnostic test
Abbreviated PB MRI which targets table time of 10 minutes. For MRI acquisition, standard dose of commercially available MR contrast agent (Gadovist, Bayer, Germany) is used on weight-based dosing (0.1mmol/kg).
| Study group | Role | What they receive |
|---|---|---|
| Follow-up participants | Experimental | Patients who met eligibility criteria. Participants are going to undergo Abbreviated PB MRI. Receives: Diagnostic Test: Abbreviated PB MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Table time of Abbreviated PB MRI
total scan time
Measured: 1 day after PB MRI acquisition
Secondary outcomes (4)
In room time of Abbreviated PB MRI
time spent in room by participants (difference between walk-in and walk-out times)
Measured: 1 day after PB MRI acquisition
Diagnostic confidence
subjective diagnostic confidence for pancreas cystic neoplasm on five point scale
Measured: 6 months after participants enrollment
Image quality
overall image quality of Abbreviated PB MRI
Measured: 6 months after participants enrollment
Requirement for re-examination
clinical need for re-examination due to suboptimal image quality
Measured: 6 months after participants enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start5 Nov 2018
- Primary completion12 Nov 2019
- Study completion4 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CystStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeong Hee Yoon, Seoul National University Hospital
- Investigators
- Jeong Hee Yoon, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03731819
- Sponsor's protocol ID
- SNUH-2018-1276
- Status last verified
- May 2022
- First submitted
- 3 Nov 2018
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of Abbreviated Pancreatobiliary MRI Using Compressed Sensing Technique for Pancreas Cystic Neoplasm Follow-up
- ClinicalTrials.gov ID
- NCT03731819
- Acronym / sponsor ID
- SNUH-2018-1276
- Keywords
- MRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- 12 Nov 2019 (actual)
- Study completion
- 4 May 2022 (actual)
- First posted
- 6 Nov 2018 (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.
This study aims to establish abbreviated PB MRI protocol for patients on regular imaging follow-up for pancreas cystic neoplasm.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Follow-up participants | Experimental | Diagnostic Test: Abbreviated PB MRIPatients who met eligibility criteria. Participants are going to undergo Abbreviated PB MRI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- on follow-up for pancreas intraductal mucinous neoplasm
- OR incidentally detected pancreas cyst (equal to or larger than 1cm)
- AND scheduled for CECT or has CECT within a months
- AND sign informed consent
Key exclusion criteria (6 listed)
- Any absolute or relative contra-indication for contrast-enhanced MRI
- No pancreas cystic neoplasm
- History of pancreatectomy
- History of any procedure for pancreatic cyst (ablation, aspiration...) in a year
- Hemosiderosis
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 |
|---|---|---|
| Abbreviated PB MRIAbbreviated PB MRI which targets table time of 10 minutes. For MRI acquisition, standard dose of commercially available MR contrast agent (Gadovist, Bayer, Germany) is used on weight-based dosing (0.1mmol/kg). | Diagnostic test | Follow-up participants |
Primary outcome
Table time of Abbreviated PB MRI
Time frame: 1 day after PB MRI acquisition
total scan time
4 secondary outcomes
In room time of Abbreviated PB MRI
Time frame: 1 day after PB MRI acquisition
Diagnostic confidence
Time frame: 6 months after participants enrollment
Image quality
Time frame: 6 months after participants enrollment
Requirement for re-examination
Time frame: 6 months after participants enrollment
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 5 May 2022.
- 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.
Jeong Hee Yoon, MD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abbreviated PB MRI in people with Pancreas Cyst and Intraductal Papillary Mucinous Neoplasm, run by Seoul National University Hospital at 1 site in South Korea.
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 4 inclusion and 6 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 5 May 2022. 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 South Korea. 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?
Table time of Abbreviated PB MRI (time frame: 1 day after PB MRI acquisition). 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 5 May 2022.