CT Radiomic Features of Pancreatic Neuroendocrine Neoplasms

Pancreatic Neuroendocrine Tumor Clinical Trial

Official title:

CT Radiomic Features of Pancreatic Neuroendocrine Neoplasms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03967951
• Other study ID #: panNEN
• Status: Completed
• Start date: March 23, 2019
• Est. completion date: May 6, 2019

Study information

• Verified date: December 2019
• Source: IRCCS San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 on CT scans.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: May 6, 2019
• Est. primary completion date: May 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Neuroendocrine Tumors
• Pancreatic Neuroendocrine Tumor

Intervention

Other:
• CT 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.

Locations

Country	Name	City	State
Italy	Deaprtment of Radiology, IRCCS Ospadale San Raffaele	Milano
Italy	IRCCS Ospedale San Raffaele	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Francesco De Cobelli

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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 [(18)F]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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interobserver variability in delineating panNENs on CT	Asses inter-observer variability on CT- scans (with contrast alone)	6 months
Secondary	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	6 months