Pancreas NeoplasmNCT04783844
Usefulness of 3D Digital Reconstruction in the Imaging Diagnosis of Pancreatic Tumors
An observational study of Pancreas Neoplasm, run by Hospital Universitario Virgen de la Arrixaca at 1 site in Spain.
Trial summary
Reconstruction using 3D virtual models has brought about a revolution in diagnostic imaging and its use is increasingly widespread. The objective of this work is to determine the precision of the 3D model when establishing the characteristics of tumors and their relationship with other anatomical structures. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pancreas Neoplasm
- What is being tested?
- Virtual modelization.
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2019to 1 May 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with suspected pancreatic tumor.
Who may be able to join
- Patients with suspected pancreatic tumor.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
David Ferreras
Murcia, 30120
David Ferreras, MD, 0034968369677, david_99db@hotmail.com
About this study
Reconstruction using 3D virtual models has brought about a revolution in diagnostic imaging and its use is increasingly widespread. The objective of this work is to determine the precision of the 3D model when establishing the characteristics of tumors and their relationship with other anatomical structures.
- Conditions
- Pancreas Neoplasm
- Being tested
- Virtual modelization.
- Keywords
- 3D virtual model
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual modelization.Diagnostic test
3D-MSP technology is used to make virtual 3D models based on conventional CT.
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy
To evaluate the correlation between the findings in the virtual model and in the CT.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start1 Oct 2019
- Primary completion1 May 2021 (estimated)
- Study completion1 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas NeoplasmStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Virgen de la Arrixaca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Ferreras, Hospital Universitario Virgen de la Arrixaca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04783844
- Sponsor's protocol ID
- Virtual pancreas
- Status last verified
- Mar 2021
- First submitted
- 2 Mar 2021
- Last updated
- 9 Mar 2021
- 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 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of 3D Digital Reconstruction in the Imaging Diagnosis of Pancreatic Tumors
- ClinicalTrials.gov ID
- NCT04783844
- Acronym / sponsor ID
- Virtual pancreas
- Conditions
- Pancreas Neoplasm
- Keywords
- 3D virtual model
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospital Universitario Virgen de la ArrixacaUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 May 2021 (estimated)
- Study completion
- 1 May 2021 (estimated)
- First posted
- 5 Mar 2021 (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.
Reconstruction using 3D virtual models has brought about a revolution in diagnostic imaging and its use is increasingly widespread. The objective of this work is to determine the precision of the 3D model when establishing the characteristics of tumors and their relationship with other anatomical structures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with suspected pancreatic tumor.
Key inclusion criteria (1 listed)
- Patients with suspected pancreatic tumor.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Virtual modelization.3D-MSP technology is used to make virtual 3D models based on conventional CT. | Diagnostic test | – |
Primary outcome
Accuracy
Time frame: 1 day
To evaluate the correlation between the findings in the virtual model and in the CT.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreas Neoplasm, run by Hospital Universitario Virgen de la Arrixaca at 1 site in Spain.
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 1 inclusion and 0 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 9 Mar 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 Spain. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy (time frame: 1 day). 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 9 Mar 2021.