EORTC-endorsed, Prospective European Multicenter Imaging Survey and Protocol

Study Overview
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Brief Summary
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A prospective, multicenter imaging Delphi survey among European radiological societies for mCRC imaging standardization.

Detailed Description
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BACKGROUND: Computed Tomography (CT) is the imaging reference standard for initial staging and response assessment in randomized, controlled clinical trials (RCT) dealing with metastatic colorectal cancer (mCRC). However, comparability of imaging data among recruiting centers in RCTs is highly hampered by diverging imaging protocols and different technical specifications. Over the last years, analysis of radiomic features in mCRC patients has gained increasing interest for image evaluation beyond the mere assessment of extent. Also, these radiomic features are highly susceptible to technical parameters such as slice thickness. Hence, comparability of radiomic features among recruiting centers are also highly limited due to diverging imaging protocols. AIMS: This prospective, multicenter imaging survey aims at assessing current differences regarding mCRC CT imaging protocols and technical specifications among large academic sites in Europe and at drafting a consensus imaging protocol endorsed by the European Organisation for Research and Treatment of Cancer (EORTC). METHODS: This survey will be in close cooperation of the EORTC Imaging Group, EORTC Gastro-intestinal Tract Group, European Society of Oncologic Imaging (ESOI) and European Society of Gastrointestinal and Abdominal Radiology (ESGAR). Among the EORTC Imaging Group, EORTC Gastro-intestinal Tract Group, ESOI and ESGAR, imaging experts will be prospectively recruited and will serve as expert panelists in this prospective survey. Following the Delphi approach for survey conduction, several survey rounds will be performed. The answers of each survey round will be analyzed by the survey facilitators, blinded results will then be forwarded to the expert panelists prior to every following survey round. Statements / answers can then be modified by the expert panelists in the following survey round.

Official Title
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Towards Standardization of mCRC Imaging - an EORTC-endorsed, Prospective European Multicenter Imaging Survey and Imaging Protocol

Conditions
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Metastatic Colorectal Cancer

Intervention / Treatment
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* Other: Imaging survey
* Other: Facilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Researchers / academics with expertise in gastro-intestinal / oncologic imaging Association with EORTC Imaging Group, EORTC GI Group, ESGAR or ESOI. Exclusion Criteria: Participants not meeting the inclusion criteria

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Expert panelists<br>Expert panelists will be recruited from EORTC Imaging Group, EORTC GI Group, ESOI and ESGAR and will actively participate in the imaging survey rounds. | Other: Imaging survey<br>* Participation as expert panelist in the imaging survey.<br>|
| Facilitators<br>The two central facilitators will moderate and guide the survey rounds. Blinded results will be forwarded to the expert panelists by the facilitators. Further Survey rounds will be adapted by the facilitators according to the previous answers given by the panelists. | Other: Facilitation<br>* Moderation and evaluation of the expert panel's answers. Adoption and moderation of further survey rounds.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standardized imaging protocol consensus among panelists | Standardized imaging protocol among panelists after multiple rounds of Delphi consensus survey (technical parameters, e. g. contrast phases, oral contrast etc.) | 6 months after finalization of the last survey round | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of technical comparability of datasets for radiomic and AI analyses | During the Delphi-survey, local information regarding technical specifications in their departments (e. g. vendor, scanner type, contrast phases, slice thickness, oral contrast, kV, etc.) will be enquired. The results will be reported as descriptive statistics, e. g. on percentage distribution of a particular technical feature. This analyses will be performed with special regards to technical parameters that knowingly have a major impact on reproducibility of Radiomics features. | 6 months after finalization of the last survey round | 
| Description of heterogeneity of mCRC imaging protocols | During the Delphi-survey, local information regarding technical specifications in their departments (e. g. vendor, scanner type, contrast phases, slice thickness, oral contrast, kV, etc.) will be enquired. The results will be reported as descriptive statistics, e. g. on percentage distribution of a particular technical feature. | 6 months after finalization of the last survey round | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Computed Tomography (CT), Radiomics, Delphi Survey, PET/CT, Expert Panelists, Standardization, Imaging protocol