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Pancreas CancerNCT02944006

Establishment of Radiomics Database by Clinical Application of Multiparametric MRI Based on Incoherent Undersampling

An observational study of Pancreas Cancer, run by Seoul National University Hospital at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study aims to establish radiomics database for pancreas cancer from multiparametric MRI including DCE-MRI obtained by using incoherent undersampling and radial acquisition for clinical staging as well as quantitative analysis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreas Cancer
What is being tested?
multi-parametric MRI
Type of treatment
Surgery or procedure
How many people
29 participants
Where
1 siteSouth Korea
Study dates
28 Nov 2016to Nov 2023
Phase
Observational
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

Study population: Patients who are scheduled to undergo pancreatobiliary MRI as a preoperative workup for suspected resectable pancreas cancer (adenocarcinoma)

Who may be able to join

  • surgical candidate for pancreatico-duodenectomy
  • characteristic finding of pancreatic adenocarcinoma on prior CT or MRI
  • OR histologically diagnosed with pancreatic adenocarcinoma
  • signed for informed consent

Who cannot join

  • under 18 years
  • not eligible for pancreatico-duodenectomy
  • unresectable patients (locally advanced on prior CT/MRI or metastatic disease)
  • tumors with suspicion of other histologic types (neuroendocrine, IPMN, etc)
  • any contra-indication of contrast-enhanced MRI
  • recurred pancreatic cancer

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Hospital

    Seoul

Other trials in South Korea

About this study

Official title: Establishment of Radiomics Database by Clinical Application of Multiparametric MRI Including DCE-MRI Based on Incoherent Undersampling

This study aims to establish radiomics database for pancreas cancer from multiparametric MRI including DCE-MRI obtained by using incoherent undersampling and radial acquisition for clinical staging as well as quantitative analysis.

Conditions
Pancreas Cancer
Being tested
multi-parametric MRI
Keywords
MRI
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • multi-parametric MRIProcedure or surgery

    multiparametric MRI is performed in all patients, and the sequence includes dynamic contrast enhanced (DCE) MRI, diffusion weighted imaging (DWI), tissue maps, and MR cholangiography.

What is being measured

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

  1. T-staging

    T-staging of the tumor at MRI.

    Measured: 4 weeks after MR acquisition

Secondary outcomes (10)

  1. N-staging

    N-staging of the tumor at MRI

    Measured: 4 weeks after MR acquisition

  2. arterial blood flow

    arterial blood flow of the tumor and adjacent parenchma on DCE-MRI

    Measured: 4 weeks after MR acquisition

  3. arterial fraction

    arterial fraction of the tumor and adjacent parenchyma on DCE-MRI

    Measured: 4 weeks after MR acquisition

  4. mean transit time

    mean transit time of the tumor and adjacent parenchyma on DCE-MRI

    Measured: 4 weeks after MR acquisition

  5. extracellular volume

    extracellular volume of the tumor and adjacent parenchyma on DCE-MRI

    Measured: 4 weeks after MR acquisition

  6. true diffusion

    true diffusion of the tumor and adjacent parenchyma on DWI with intravoxel incoherent motion model

    Measured: 4 weeks after MR acquisition

  7. pseudodiffusion

    pseudodiffusion of the tumor and adjacent parenchyma on DWI with intravoxel incoherent motion model

    Measured: 4 weeks after MR acquisition

  8. perfusion fraction

    perfusion fraction of the tumor and adjacent parenchyma on DWI with intravoxel incoherent motion model

    Measured: 4 weeks after MR acquisition

  9. kurtosis

    kurtosis of the tumor and adjacent parenchyma on DWI with kurtosis model

    Measured: 4 weeks after MR acquisition

  10. mean diffusivity

    mean diffusivity of the tumor and adjacent parenchyma on DWI with kurtosis model

    Measured: 4 weeks after MR acquisition

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 2016 (estimated)
  2. Study start28 Nov 2016
  3. Primary completionDec 2022 (estimated)
  4. Study completionNov 2023 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02944006
Sponsor's protocol ID
2015-1160
Status last verified
Dec 2021
First submitted
24 Oct 2016
Last updated
17 Dec 2021
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of 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 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: status not confirmed, as of the sponsor's last update on 17 Dec 2021. 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?

Results are not available in the source record.

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?

T-staging (time frame: 4 weeks after MR acquisition). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02944006.

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 17 Dec 2021.

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