Pancreatic Neuroendocrine TumorNCT03967951
CT Radiomic Features of Pancreatic Neuroendocrine Neoplasms
An observational study of Pancreatic Neuroendocrine Tumor, run by Francesco De Cobelli at 2 sites in Italy.
Trial summary
The aim of this study is to quantify inter-observer variability in delineating pancreatic neuroendocrine neoplasm (PanNEN) on Computerized Tomography (CT) images and its impact on radiomic features (RF), subsequently to this determination, to use CT texture analysis to predict, histological characteristics of PanNEN… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Neuroendocrine Tumor
- What is being tested?
- CT radiomic feature evaluation
- How many people
- 70 participants
- Where
- 2 sitesItaly
- Study dates
- 23 Mar 2019to 6 May 2019
- 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: Monocentric, retrospective, observational study. Subjects who fulfill the inclusion criteria will be randomly chosen from our Institutional data-base. Thirty patients will be used to evaluate inter-observer variability and forty patients will be used to evaluate histological characteristics on CT-scans with and without contrast agent). Imaged based and clinical variables will be used to construct an overall status of the patient.
Who may be able to join
- > 18 years of age
- pancreatic neuroendocrine neoplasm with intervention and biopsy
- availability of pre-operatory CT scan with or without IV contrast agent- inInstitution from 2009-2017
Who cannot join
- pregnant women
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Deaprtment of Radiology, IRCCS Ospadale San Raffaele
Milan, 20132
IRCCS Ospedale San Raffaele
Milan, 20153
About this study
The aim of this study is to quantify inter-observer variability in delineating pancreatic neuroendocrine neoplasm (PanNEN) on Computerized Tomography (CT) images and its impact on radiomic features (RF), subsequently to this determination, to use CT texture analysis to predict, histological characteristics of PanNEN on CT scans.
Read the detailed description
CT imaging is the most widely used modality for studying radiomic features due to its ability to assess tissue density, shape, texture and size before, during and after therapy. To the best of the investigator's knowledge, the impact of inter-observer delineation variability on the reliability of CT RF for PanNEN patients, including Hounsfield unit (HU) values-, shape-, and texture-based features, has not yet been assessed. One this has been determined, an additional evaluation will be conducted to correlate the morphologically observed images with their histopathological characteristics.
The ultimate potential objective of this research is to identify and predict characteristics of aggressiveness of PanNEN in CT scans.
- Conditions
- Pancreatic Neuroendocrine Tumor
- Being tested
- CT radiomic feature evaluation
- Keywords
- Radiomics, Pancretic neuroendocrine neoplasms (panNEN)
- Medical subject headings
- Adenoma, Islet Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT radiomic feature evaluationOther
Radiomic features will be calculated and extracted from all contrast and non-contrast CT-scans. First order features will be evaluated and high order features will be grouped in parent matrices. Parent matrices of second and third order will be chosen and evaluated.
In the second part, based on the results of inter-correlation of the operator analysis, the most significant radiomic features will be chosen. Morphological and histopathological features will be evaluated will be.
Histopathology will be performed on a biopsy specimen; percentage of Ki67 and grading will be evaluated.
What is being measured
The primary outcome is the main question the study is designed to answer.
Interobserver variability in delineating panNENs on CT
Asses inter-observer variability on CT- scans (with contrast alone)
Measured: 6 months
Secondary outcomes (1)
Use CT texture analysis to predict, histological characteristics of PanNEN on CT scans
Evaluate histological characteristics on CT-scans with and without contrast agent in a group of subjects
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start23 Mar 2019
- Primary completion6 May 2019
- Study completion6 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pancreatic Neuroendocrine TumorStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Francesco De Cobelli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Francesco De Cobelli, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03967951
- Sponsor's protocol ID
- panNEN
- Status last verified
- Dec 2019
- First submitted
- 27 May 2019
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Belli ML, Mori M, Broggi S, Cattaneo GM, Bettinardi V, Dell'Oca I, Fallanca F, Passoni P, Vanoli EG, Calandrino R, Di Muzio N, Picchio M, Fiorino C. Quantifying the robustness of [18F]FDG-PET/CT radiomic features with respect to tumor delineation in head and neck and pancreatic cancer patients. Phys Med. 2018 May;49:105-111. doi: 10.1016/j.ejmp.2018.05.013. Epub 2018 May 23.
PubMed 29866335Benedetti G, Mori M, Panzeri MM, Barbera M, Palumbo D, Sini C, Muffatti F, Andreasi V, Steidler S, Doglioni C, Partelli S, Manzoni M, Falconi M, Fiorino C, De Cobelli F. CT-derived radiomic features to discriminate histologic characteristics of pancreatic neuroendocrine tumors. Radiol Med. 2021 Jun;126(6):745-760. doi: 10.1007/s11547-021-01333-z. Epub 2021 Feb 1.
PubMed 33523367
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT Radiomic Features of Pancreatic Neuroendocrine Neoplasms
- ClinicalTrials.gov ID
- NCT03967951
- Acronym / sponsor ID
- panNEN
- Conditions
- Pancreatic Neuroendocrine Tumor
- Keywords
- Radiomics, Pancretic neuroendocrine neoplasms (panNEN)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Francesco De CobelliUniversity, hospital or other
- Study start
- 23 Mar 2019 (actual)
- Primary completion
- 6 May 2019 (actual)
- Study completion
- 6 May 2019 (actual)
- First posted
- 30 May 2019 (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.
The aim of this study is to quantify inter-observer variability in delineating pancreatic neuroendocrine neoplasm (PanNEN) on Computerized Tomography (CT) images and its impact on radiomic features (RF), subsequently to this determination, to use CT texture analysis to predict, histological characteristics of PanNEN on CT scans.
Detailed description
CT imaging is the most widely used modality for studying radiomic features due to its ability to assess tissue density, shape, texture and size before, during and after therapy. To the best of the investigator's knowledge, the impact of inter-observer delineation variability on the reliability of CT RF for PanNEN patients, including Hounsfield unit (HU) values-, shape-, and texture-based features, has not yet been assessed. One this has been determined, an additional evaluation will be conducted to correlate the morphologically observed images with their histopathological characteristics.
The ultimate potential objective of this research is to identify and predict characteristics of aggressiveness of PanNEN in CT scans.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Monocentric, retrospective, observational study. Subjects who fulfill the inclusion criteria will be randomly chosen from our Institutional data-base. Thirty patients will be used to evaluate inter-observer variability and forty patients will be used to evaluate histological characteristics on CT-scans with and without contrast agent). Imaged based and clinical variables will be used to construct an overall status of the patient.
Key inclusion criteria (3 listed)
- > 18 years of age
- pancreatic neuroendocrine neoplasm with intervention and biopsy
- availability of pre-operatory CT scan with or without IV contrast agent- inInstitution from 2009-2017
Key exclusion criteria (1 listed)
- pregnant women
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 |
|---|---|---|
| CT radiomic feature evaluationRadiomic features will be calculated and extracted from all contrast and non-contrast CT-scans. First order features will be evaluated and high order features will be grouped in parent matrices. Parent matrices of second and third order will be chosen and evaluated. In the second part, based on the results of inter-correlation of the operator analysis, the most significant radiomic features will be chosen. Morphological and histopathological features will be evaluated will be. Histopathology will be performed on a biopsy specimen; percentage of Ki67 and grading will be evaluated. | Other | – |
Primary outcome
Interobserver variability in delineating panNENs on CT
Time frame: 6 months
Asses inter-observer variability on CT- scans (with contrast alone)
1 secondary outcome
Use CT texture analysis to predict, histological characteristics of PanNEN on CT scans
Time frame: 6 months
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 23 Sep 2026.
- Background: PubMed 29866335Belli ML, Mori M, Broggi S, Cattaneo GM, Bettinardi V, Dell'Oca I, Fallanca F, Passoni P, Vanoli EG, Calandrino R, Di Muzio N, Picchio M, Fiorino C. Quantifying the robustness of [18F]FDG-PET/CT radiomic features with respect to tumor delineation in head and neck and pancreatic cancer patients. Phys Med. 2018 May;49:105-111. doi: 10.1016/j.ejmp.2018.05.013. Epub 2018 May 23.
- Derived from this study: PubMed 33523367Benedetti G, Mori M, Panzeri MM, Barbera M, Palumbo D, Sini C, Muffatti F, Andreasi V, Steidler S, Doglioni C, Partelli S, Manzoni M, Falconi M, Fiorino C, De Cobelli F. CT-derived radiomic features to discriminate histologic characteristics of pancreatic neuroendocrine tumors. Radiol Med. 2021 Jun;126(6):745-760. doi: 10.1007/s11547-021-01333-z. Epub 2021 Feb 1.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Neuroendocrine Tumor, run by Francesco De Cobelli at 2 sites in Italy.
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 1 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 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
Interobserver variability in delineating panNENs on CT (time frame: 6 months). 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 NCT03967951, which also lists 2 linked publications.
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 23 Sep 2026.