CT Radiomic Features of Pancreatic Neuroendocrine Neoplasms

Completed

• Conditions: Pancreatic Neuroendocrine Tumor

• Registration Number: NCT03967951
• Lead Sponsor: Francesco De Cobelli

Brief 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.

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 Timeline

• Study Start: 2019-03-23
• Primary Completion: 2019-05-06
• Study Completion: 2019-05-06
• Study First Submitted: 2019-05-27
• Study First Submitted QC: 2019-05-29
• Study First Posted: 2019-05-30
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-24
• Last Update Posted: 2019-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

• pregnant women

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Interobserver variability in delineating panNENs on CT	6 months	Asses inter-observer variability on CT- scans (with contrast alone)

Secondary Outcome Measures

Name	Time	Method
Use CT texture analysis to predict, histological characteristics of PanNEN on CT scans	6 months	Evaluate histological characteristics on CT-scans with and without contrast agent in a group of subjects

Trial Locations

Locations (2)

Deaprtment of Radiology, IRCCS Ospadale San Raffaele; 🇮🇹 Milano, Italy

IRCCS Ospedale San Raffaele; 🇮🇹 Milano, Italy