2019-03-23
2019-05-06
2019-05-06
70
NCT03967951
IRCCS San Raffaele
IRCCS San Raffaele
OBSERVATIONAL
CT Radiomic Features of Pancreatic Neuroendocrine Neoplasms
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates | Results Reporting Dates | Study Record Updates |
---|---|---|
2019-05-27 | N/A | 2019-12-24 |
2019-05-29 | N/A | 2019-12-26 |
2019-05-30 | N/A | 2019-12 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
Participant Group/Arm | Intervention/Treatment |
---|
Primary Outcome Measures | Measure Description | Time Frame |
---|---|---|
Interobserver variability in delineating panNENs on CT | Asses inter-observer variability on CT- scans (with contrast alone) | 6 months |
Secondary Outcome Measures | Measure Description | Time Frame |
---|---|---|
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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications