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CompletedNCT03967951Updated Sep 23, 2026

CT Radiomic Features of Pancreatic Neuroendocrine Neoplasms

An observational study in Pancreatic Neuroendocrine Tumor, sponsored by Francesco De Cobelli. Completed at 2 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.

Sponsored by Francesco De Cobelli · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
70
Ages
18 Years and older
Sex
All
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Study 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 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.

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Conditions studied

  • Pancreatic Neuroendocrine Tumor

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Keywords

  • Radiomics
  • Pancretic neuroendocrine neoplasms (panNEN)
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In context

Adenoma, Islet Cell

102 studies on the registry are indexed under Adenoma, Islet Cell; 26 are open to participants now.

This study's enrollment of 70 is below the median of 85 across 22 observational studies indexed under Adenoma, Islet Cell.

Browse Adenoma, Islet Cell studies →

Lead sponsor

Francesco De Cobelli is the lead sponsor of 6 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

  • > 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

Exclusion criteria

Exclusion Criteria:

  • pregnant women
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Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
70 participants (actual)
Patient registry
No

Interventions

  • OtherCT radiomic feature evaluation

    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.

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What researchers measure

Primary outcomes

  1. Interobserver variability in delineating panNENs on CT

    Asses inter-observer variability on CT- scans (with contrast alone)

    Time frame: 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

    Time frame: 6 months

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Study locations

2 sites
  • Deaprtment of Radiology, IRCCS Ospadale San Raffaele
    Milan, 20132, Italy
  • IRCCS Ospedale San Raffaele
    Milan, 20153, Italy
08

References and documents

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 29866335 ↗
  • Benedetti 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 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03967951
Lead sponsor
Francesco De Cobelli
Responsible party
Francesco De Cobelli (Professor of Radiology, Head of Clinical and Experimental Radiology, IRCCS San Raffaele) — Sponsor-investigator
First posted
May 30, 2019
Start date
Mar 23, 2019
Primary completion
May 6, 2019
Completion
May 6, 2019
Last update
Sep 23, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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