Pancreas CancerNCT04592393
Pancreas Cancer Surveillance Using an Abbreviated MRI
A study testing Abbreviated PB MRI, Gene mutation test and Conventional follow-up in people with Pancreas Cancer, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study aims to establish a prospective cohort of developing pancreas cancer and surveillance MRI protocol. With the focused surveillance protocol, we perform surveillance for pancreas cancer for five years to estimate the risk of pancreas cancer and the clinical feasibility of the surveillance MRI. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Pancreas Cancer
- What is being tested?
- Abbreviated PB MRI, Gene mutation test and Conventional follow-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Oct 2020to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- On follow-up due to first degree-family history of PAC
- Or on follow-up for BD-IPMN (>= 2 cm) or main-duct type IPMN (> 5 mm)
- And signed informed consent
Who cannot join
- Contra-indication of performing MRI
- Not satisfying the selection criteria.
- Previously diagnosed with pancreatic malignancy
- Pregnancy or planning pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Feasibility of Abbreviated MRI for Surveillance in High Risk Group for Developing Pancreas Cancer: A Prospective Cohort Study
This study aims to establish a prospective cohort of developing pancreas cancer and surveillance MRI protocol. With the focused surveillance protocol, we perform surveillance for pancreas cancer for five years to estimate the risk of pancreas cancer and the clinical feasibility of the surveillance MRI.
- Conditions
- Pancreas Cancer
- Being tested
- Abbreviated PB MRI, Gene mutation test, Conventional follow-up
- Keywords
- pancreas cancer, intraductal papillary mucinous neoplasm, magnetic resonance imaging
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abbreviated PB MRIDiagnostic test
Annual non-contrast PB MRI.
Gene mutation testGenetic
K-ras and GNAS mutation test. Being performed once as a baseline test at the enrollment.
Conventional follow-upDiagnostic test
Any of followings: scheduled CECT, MRI, USG, EUS, tumor marker (CA 19-9) during the study period.
| Study group | Role | What they receive |
|---|---|---|
| Abbreviated PB MRI | Experimental | Short and Focused non-contrast MRI for surveillance Receives: Diagnostic Test: Abbreviated PB MRI; Genetic: Gene mutation test; Diagnostic Test: Conventional follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of pancreas cancer
number of detected pancreas cancer (resectable \& BRPC only) in surveillance MRI.
Measured: 1 year after the last surveillance MRI.
Secondary outcomes (3)
Scan time of abbreviated PB MRI for surveillance
table time, in-room time measurement for feasibility
Measured: 1 month after the first surveillance MRI.
Estimation of pancreas cancer risk
rate of developing pancreas cancer during the study period
Measured: 1 year after the last surveillance MRI.
Detection of pancreas cancer
number of detected pancreas cancer of all stages (resectable, BRPC, LAPC, metastatic) in surveillance MRI.
Measured: 1 year after the last surveillance MRI.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start28 Oct 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CancerStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Foundation of Korea
- Responsible party
- Principal investigator, Jeong Min Lee, Seoul National University Hospital
- Investigators
- Jeong Min Lee, MD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04592393
- Sponsor's protocol ID
- SNUH-2020-2950
- Status last verified
- Aug 2023
- First submitted
- 7 Oct 2020
- Last updated
- 18 Aug 2023
- 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 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Feasibility of Abbreviated MRI for Surveillance in High Risk Group for Developing Pancreas Cancer: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04592393
- Acronym / sponsor ID
- SNUH-2020-2950
- Conditions
- Pancreas Cancer
- Keywords
- pancreas cancer, intraductal papillary mucinous neoplasm, magnetic resonance imaging
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- National Research Foundation of Korea
- Study start
- 28 Oct 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 19 Oct 2020 (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 a prospective cohort of developing pancreas cancer and surveillance MRI protocol. With the focused surveillance protocol, we perform surveillance for pancreas cancer for five years to estimate the risk of pancreas cancer and the clinical feasibility of the surveillance MRI.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abbreviated PB MRI | Experimental | Diagnostic Test: Abbreviated PB MRI, Genetic: Gene mutation test, Diagnostic Test: Conventional follow-upShort and Focused non-contrast MRI for surveillance |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- On follow-up due to first degree-family history of PAC
- Or on follow-up for BD-IPMN (>= 2 cm) or main-duct type IPMN (> 5 mm)
- And signed informed consent
Key exclusion criteria (4 listed)
- Contra-indication of performing MRI
- Not satisfying the selection criteria.
- Previously diagnosed with pancreatic malignancy
- Pregnancy or planning pregnancy
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 MRIAnnual non-contrast PB MRI. | Diagnostic test | Abbreviated PB MRI |
| Gene mutation testK-ras and GNAS mutation test. Being performed once as a baseline test at the enrollment. | Genetic | Abbreviated PB MRI |
| Conventional follow-upAny of followings: scheduled CECT, MRI, USG, EUS, tumor marker (CA 19-9) during the study period. | Diagnostic test | Abbreviated PB MRI |
Primary outcome
Detection of pancreas cancer
Time frame: 1 year after the last surveillance MRI.
number of detected pancreas cancer (resectable \& BRPC only) in surveillance MRI.
3 secondary outcomes
Scan time of abbreviated PB MRI for surveillance
Time frame: 1 month after the first surveillance MRI.
Estimation of pancreas cancer risk
Time frame: 1 year after the last surveillance MRI.
Detection of pancreas cancer
Time frame: 1 year after the last surveillance MRI.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
- 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 Min Lee, MD principal investigator
Professor
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, Gene mutation test and Conventional follow-up in people with Pancreas Cancer, 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 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: under way, not looking for participants, as of the sponsor's last update on 18 Aug 2023. 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?
This study is still under way. Results are not available in the source record yet.
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?
Detection of pancreas cancer (time frame: 1 year after the last surveillance MRI.). 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 18 Aug 2023.