Clinical trial NCT03967951: CT Radiomic Features of Pancreatic Neuroendocrine Neoplasms
Official title: CT Radiomic Features of Pancreatic Neuroendocrine Neoplasms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Neuroendocrine Tumor
Keywords: Radiomics
Pancretic neuroendocrine neoplasms (panNEN)
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2019-05-30
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Interobserver variability in delineating panNENs on CT
timeFrame: 6 months
Secondary outcomes:
measure: Use CT texture analysis to predict, histological characteristics of PanNEN on CT scans
timeFrame: 6 months
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Deaprtment of Radiology, IRCCS Ospadale San Raffaele
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele
Study officials:
References:
citation: 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.
citation: 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.