EORTC-endorsed, Prospective European Multicenter Imaging Survey and Protocol

NCT ID: NCT04656782

Last Updated: 2021-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-26

Study Completion Date

2021-12-31

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.

Conditions

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Metastatic Colorectal Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Imaging survey

Intervention Type OTHER

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.

Facilitation

Intervention Type OTHER

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

Interventions

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Imaging survey

Participation as expert panelist in the imaging survey.

Intervention Type OTHER

Facilitation

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

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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EORTC Imaging Group

UNKNOWN

Sponsor Role collaborator

EORTC Gastrointestinal Tract Cancer Cooperative Group

OTHER

Sponsor Role collaborator

European Society of Oncologic Imaging (ESOI)

UNKNOWN

Sponsor Role collaborator

European Society of Gastrointestinal and Abdominal Radiology (ESGAR)

UNKNOWN

Sponsor Role collaborator

Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Marcus Unterrainer

Resident, Department of Radiology, University Hospital, LMU Munich

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marcus Unterrainer

Role: PRINCIPAL_INVESTIGATOR

Dept. of Radiology, University Hospital, LMU Munich

Wolfgang G Kunz

Role: PRINCIPAL_INVESTIGATOR

Dept. of Radiology, University Hospital, LMU Munich

Locations

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Dept. of Radiology, University Hospital, LMU Munich

Munich, Bavaria, Germany

Site Status

Countries

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Germany

Related Links

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http://www.esoi-society.org/

European Society of Oncologic Imaging

https://www.esgar.org/

European Society of Gastrointestinal and Abdominal Radiology

Other Identifiers

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EORTC imaging survey

Identifier Type: -

Identifier Source: org_study_id

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