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出境医 / 临床实验 / CT Radiomic Features of Pancreatic Neuroendocrine Neoplasms

CT Radiomic Features of Pancreatic Neuroendocrine Neoplasms

Study Description
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.

Condition or disease Intervention/treatment
Pancreatic Neuroendocrine Tumor Other: CT radiomic feature evaluation

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
Layout table for study information
Study Type : Observational
Actual Enrollment : 70 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: CT Radiomic Features of Pancreatic Neuroendocrine Neoplasms
Actual Study Start Date : March 23, 2019
Actual Primary Completion Date : May 6, 2019
Actual Study Completion Date : May 6, 2019
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Interobserver variability in delineating panNENs on CT [ Time Frame: 6 months ]
    Asses inter-observer variability on CT- scans (with contrast alone)


Secondary Outcome Measures :
  1. Use CT texture analysis to predict, histological characteristics of PanNEN on CT scans [ Time Frame: 6 months ]
    Evaluate histological characteristics on CT-scans with and without contrast agent in a group of subjects


Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date May 27, 2019
First Posted Date May 30, 2019
Last Update Posted Date December 26, 2019
Actual Study Start Date March 23, 2019
Actual Primary Completion Date May 6, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 30, 2019) 		Interobserver variability in delineating panNENs on CT [ Time Frame: 6 months ]
Asses inter-observer variability on CT- scans (with contrast alone)
Original Primary Outcome Measures
 (submitted: May 29, 2019) 		Interobserver variability in deliniating panNENs on CT [ Time Frame: 6 months ]
Asses inter-observer variability on CT- scans (with contrast alone)
Change History
Current Secondary Outcome Measures
 (submitted: May 30, 2019) 		Use CT texture analysis to predict, histological characteristics of PanNEN on CT scans [ Time Frame: 6 months ]
Evaluate histological characteristics on CT-scans with and without contrast agent in a group of subjects
Original Secondary Outcome Measures
 (submitted: May 29, 2019) 		Use CT texture analysis to predict, histological characteristics of PanNEN on CT scans [ Time Frame: 6 months ]
Evaluate histological characteristics on CT-scans with and without contrast agent in a gruop of subjects
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title CT Radiomic Features of Pancreatic Neuroendocrine Neoplasms
Official Title CT Radiomic Features of Pancreatic Neuroendocrine Neoplasms
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 Type Observational
Study Design Observational Model: Other
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition 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.
Study Groups/Cohorts Not Provided
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 [(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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 29, 2019) 		70
Original Estimated Enrollment Same as current
Actual Study Completion Date May 6, 2019
Actual Primary Completion Date May 6, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT03967951
Other Study ID Numbers panNEN
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Francesco De Cobelli, IRCCS San Raffaele
Study Sponsor Francesco De Cobelli
Collaborators Not Provided
Investigators Not Provided
PRS Account IRCCS San Raffaele
Verification Date December 2019

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