Metastatic Colorectal CancerNCT04656782
EORTC-endorsed, Prospective European Multicenter Imaging Survey and Protocol
An observational study of Metastatic Colorectal Cancer, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial summary
A prospective, multicenter imaging Delphi survey among European radiological societies for mCRC imaging standardization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Imaging survey and Facilitation
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 26 Jan 2021to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Imaging experts will serve as expert panelists in the Delphi Survey and will undergo several rounds of blinded questionnaires.
Who may be able to join
- Researchers / academics with expertise in gastro-intestinal / oncologic imaging
- Association with EORTC Imaging Group, EORTC GI Group, ESGAR or ESOI.
Who cannot join
- Participants not meeting the inclusion criteria
Trial locations and contacts
1 site in 1 country.
Germany1 site
Dept. of Radiology, University Hospital, LMU Munich
Munich, Bavaria, 81377
About this study
Official title: 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.
Read the 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.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Imaging survey, Facilitation
- Keywords
- Computed Tomography (CT), Radiomics, Delphi Survey, PET/CT, Expert Panelists, Standardization, Imaging protocol
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imaging surveyOther
Participation as expert panelist in the imaging survey.
FacilitationOther
Moderation and evaluation of the expert panel's answers. Adoption and moderation of further survey rounds.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: 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. Receives: Other: Facilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: 6 months after finalization of the last survey round
Secondary outcomes (2)
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.
Measured: 6 months after finalization of the last survey round
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.
Measured: 6 months after finalization of the last survey round
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start26 Jan 2021 (estimated)
- Primary completion30 Jun 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- EORTC Imaging Group, EORTC Gastrointestinal Tract Cancer Cooperative Group, European Society of Oncologic Imaging (ESOI), European Society of Gastrointestinal and Abdominal Radiology (ESGAR)
- Responsible party
- Principal investigator, Marcus Unterrainer, Ludwig-Maximilians - University of Munich
- Investigators
- Marcus Unterrainer, Principal investigator, Dept. of Radiology, University Hospital, LMU MunichWolfgang G Kunz, Principal investigator, Dept. of Radiology, University Hospital, LMU Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04656782
- Sponsor's protocol ID
- EORTC imaging survey
- Status last verified
- Jan 2021
- First submitted
- 25 Nov 2020
- Last updated
- 26 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Towards Standardization of mCRC Imaging - an EORTC-endorsed, Prospective European Multicenter Imaging Survey and Imaging Protocol
- ClinicalTrials.gov ID
- NCT04656782
- Acronym / sponsor ID
- EORTC imaging survey
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- Computed Tomography (CT), Radiomics, Delphi Survey, PET/CT, Expert Panelists, Standardization, Imaging protocol
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Collaborators
- EORTC Imaging Group, EORTC Gastrointestinal Tract Cancer Cooperative Group, European Society of Oncologic Imaging (ESOI), European Society of Gastrointestinal and Abdominal Radiology (ESGAR)
- Study start
- 26 Jan 2021 (estimated)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 7 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Expert panelists | – | Other: Imaging surveyExpert panelists will be recruited from EORTC Imaging Group, EORTC GI Group, ESOI and ESGAR and will actively participate in the imaging survey rounds. |
| Facilitators | – | Other: FacilitationThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Imaging experts will serve as expert panelists in the Delphi Survey and will undergo several rounds of blinded questionnaires.
Key inclusion criteria (2 listed)
- Researchers / academics with expertise in gastro-intestinal / oncologic imaging
- Association with EORTC Imaging Group, EORTC GI Group, ESGAR or ESOI.
Key exclusion criteria (1 listed)
- Participants not meeting the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imaging surveyParticipation as expert panelist in the imaging survey. | Other | Expert panelists |
| FacilitationModeration and evaluation of the expert panel's answers. Adoption and moderation of further survey rounds. | Other | Facilitators |
Primary outcome
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.)
2 secondary outcomes
Description of technical comparability of datasets for radiomic and AI analyses
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
- EORTC Gastrointestinal Tract Cancer GroupLink provided by the sponsor.
- European Society of Oncologic ImagingLink provided by the sponsor.
- European Society of Gastrointestinal and Abdominal RadiologyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcus Unterrainer principal investigator
Dept. of Radiology, University Hospital, LMU Munich
Wolfgang G Kunz principal investigator
Dept. of Radiology, University Hospital, LMU Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Colorectal Cancer, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standardized imaging protocol consensus among panelists (time frame: 6 months after finalization of the last survey round). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2021.