Clinical trial NCT04656782: EORTC-endorsed, Prospective European Multicenter Imaging Survey and Protocol
Official title: Towards Standardization of mCRC Imaging - an EORTC-endorsed, Prospective European Multicenter Imaging Survey and Imaging Protocol
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metastatic Colorectal Cancer
Keywords: Computed Tomography (CT)
Radiomics
Delphi Survey
PET/CT
Expert Panelists
Standardization
Imaging protocol
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
Collaborators: name: EORTC Imaging Group
name: EORTC Gastrointestinal Tract Cancer Cooperative Group
name: European Society of Oncologic Imaging (ESOI)
name: European Society of Gastrointestinal and Abdominal Radiology (ESGAR)
First posted: 2020-12-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Imaging experts will serve as expert panelists in the Delphi Survey and will undergo several rounds of blinded questionnaires.

Brief summary: A prospective, multicenter imaging Delphi survey among European radiological societies for mCRC imaging standardization.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Standardized imaging protocol consensus among panelists
timeFrame: 6 months after finalization of the last survey round
Secondary outcomes:
measure: Description of technical comparability of datasets for radiomic and AI analyses
timeFrame: 6 months after finalization of the last survey round
measure: Description of heterogeneity of mCRC imaging protocols
timeFrame: 6 months after finalization of the last survey round
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Dept. of Radiology, University Hospital, LMU Munich
state: Bavaria
Study officials:
affiliation: Dept. of Radiology, University Hospital, LMU Munich
name: Marcus Unterrainer
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept. of Radiology, University Hospital, LMU Munich
name: Wolfgang G Kunz
role: PRINCIPAL_INVESTIGATOR
References: