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Trial record 59 of 2732 for:    Neoplasms | Neuroendocrine Tumors

CT Radiomic Features of Pancreatic Neuroendocrine Neoplasms

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ClinicalTrials.gov Identifier: NCT03967951
Recruitment Status : Recruiting
First Posted : May 30, 2019
Last Update Posted : June 3, 2019
Sponsor:
Information provided by (Responsible Party):
Francesco De Cobelli, IRCCS San Raffaele

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.


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Study Type : Observational
Estimated 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
Estimated Primary Completion Date : November 28, 2019
Estimated Study Completion Date : December 28, 2019



Intervention Details:
  • 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.



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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03967951


Contacts
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Contact: Francesco De Cobelli, MD +390226432529 decobelli.francesco@hsr.it
Contact: Stephanie Steidler, PhD +3926432529 steidler.stephanie@hsr.it

Locations
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Italy
Deaprtment of Radiology, IRCCS Ospadale San Raffaele Recruiting
Milano, Italy, 20132
Contact: Stephanie Steidler, PhD    +390226436111    steidler.stephanie@hsr.it   
Principal Investigator: Francesco De Cobelli, MD         
Sub-Investigator: Fiorino Claudio, MSc         
Sub-Investigator: Mori Martina, MSc         
IRCCS Ospedale San Raffaele Recruiting
Milano, Italy, 20153
Contact: Stephanie Steidler       steidler.stephanie@hsr.it   
Sponsors and Collaborators
Francesco De Cobelli

Publications:
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Responsible Party: Francesco De Cobelli, Professor of Radiology, Head of Clinical and Experimental Radiology, IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT03967951     History of Changes
Other Study ID Numbers: panNEN
First Posted: May 30, 2019    Key Record Dates
Last Update Posted: June 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Francesco De Cobelli, IRCCS San Raffaele:
Radiomics
Pancretic neuroendocrine neoplasms (panNEN)

Additional relevant MeSH terms:
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Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Neoplasms, Glandular and Epithelial
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Adenoma, Islet Cell
Adenoma
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases