CT Radiomic Features of Pancreatic Neuroendocrine Neoplasms

NCT03967951 | Completed

• 1 other identifier: panNEN
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 2

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.

Conditions

Pancreatic Neuroendocrine Tumor

Keywords

Radiomics; Pancretic neuroendocrine neoplasms (panNEN)

Outcome Measures

Primary Outcomes (1)

• Interobserver variability in delineating panNENs on CT

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

  6 months

Secondary Outcomes (1)

• Use CT texture analysis to predict, histological characteristics of PanNEN on CT scans

  6 months

Interventions

CT radiomic feature evaluation OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \> 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

You may not qualify if:

• pregnant women

Sponsors & Collaborators

• Francesco De Cobelli: lead

Study Sites (2)

Deaprtment of Radiology, IRCCS Ospadale San Raffaele

Milan, 20132, Italy

Location

IRCCS Ospedale San Raffaele

Milan, 20153, Italy

Location

Related Publications (2)

• 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.

  PMID: 29866335 BACKGROUND

• 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.

  PMID: 33523367 DERIVED

MeSH Terms

Conditions

Adenoma, Islet Cell

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Radiology, Head of Clinical and Experimental Radiology

Study Record Dates

• First Submitted: May 27, 2019
• First Posted: May 30, 2019
• Study Start: March 23, 2019
• Primary Completion: May 6, 2019
• Study Completion: May 6, 2019
• Last Updated: December 26, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)