EORTC-endorsed, Prospective European Multicenter Imaging Survey and Protocol

January 25, 2021 updated by: Marcus Unterrainer, Ludwig-Maximilians - University of Munich

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

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

Study Overview

Status

Enrolling by invitation

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.

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Bavaria
      • Munich, Bavaria, Germany, 81377
        • Dept. of Radiology, University Hospital, LMU Munich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Expert panelists
Expert panelists will be recruited from EORTC Imaging Group, EORTC GI Group, ESOI and ESGAR and will actively participate in the imaging survey rounds.
Participation as expert panelist in the imaging survey.
Facilitators
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.
Moderation and evaluation of the expert panel's answers. Adoption and moderation of further survey rounds.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Standardized imaging protocol consensus among panelists
Time Frame: 6 months after finalization of the last survey round
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
Time Frame: 6 months after finalization of the last survey round
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
Time Frame: 6 months after finalization of the last survey round
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Marcus Unterrainer, Dept. of Radiology, University Hospital, LMU Munich
  • Principal Investigator: Wolfgang G Kunz, Dept. of Radiology, University Hospital, LMU Munich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 26, 2021

Primary Completion (Anticipated)

June 30, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

November 25, 2020

First Submitted That Met QC Criteria

December 4, 2020

First Posted (Actual)

December 7, 2020

Study Record Updates

Last Update Posted (Actual)

January 26, 2021

Last Update Submitted That Met QC Criteria

January 25, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Metastatic Colorectal Cancer

Clinical Trials on Imaging survey

Subscribe