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EORTC-endorsed, Prospective European Multicenter Imaging Survey and Protocol

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04656782
Enrollment
40
Registered
2020-12-07
Start date
2021-01-26
Completion date
2021-12-31
Last updated
2021-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Colorectal Cancer

Keywords

Computed Tomography (CT), Radiomics, Delphi Survey, PET/CT, Expert Panelists, Standardization, Imaging protocol

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.

Interventions

OTHERImaging survey

Participation as expert panelist in the imaging survey.

Moderation and evaluation of the expert panel's answers. Adoption and moderation of further survey rounds.

Sponsors

EORTC Imaging Group
CollaboratorUNKNOWN
EORTC Gastrointestinal Tract Cancer Cooperative Group
CollaboratorOTHER
European Society of Oncologic Imaging (ESOI)
CollaboratorUNKNOWN
European Society of Gastrointestinal and Abdominal Radiology (ESGAR)
CollaboratorUNKNOWN
Ludwig-Maximilians - University of Munich
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Standardized imaging protocol consensus among panelists6 months after finalization of the last survey roundStandardized imaging protocol among panelists after multiple rounds of Delphi consensus survey (technical parameters, e. g. contrast phases, oral contrast etc.)

Secondary

MeasureTime frameDescription
Description of technical comparability of datasets for radiomic and AI analyses6 months after finalization of the last survey roundDuring 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.
Description of heterogeneity of mCRC imaging protocols6 months after finalization of the last survey roundDuring 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.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026