EORTC-endorsed, Prospective European Multicenter Imaging Survey and Protocol

Metastatic Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04656782
• Other study ID #: EORTC imaging survey
• Status: Enrolling by invitation
• Start date: January 26, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2021
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: December 31, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Other:
• Imaging survey
Participation as expert panelist in the imaging survey.
• Facilitation
Moderation and evaluation of the expert panel's answers. Adoption and moderation of further survey rounds.

Locations

Country	Name	City	State
Germany	Dept. of Radiology, University Hospital, LMU Munich	Munich	Bavaria

Sponsors (5)

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

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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

External Links

•   EORTC Gastrointestinal Tract Cancer Group
•   EORTC Imaging Group
•   European Society of Gastrointestinal and Abdominal Radiology