NCT07656181 International Delphi Study to Develop Standardized Quality Criteria and a Rating Tool for Liver CEUS Image Quality Assessment
| NCT ID | NCT07656181 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Bern |
| Condition | Contrast Enhanced Ultrasound |
| Study Type | OBSERVATIONAL |
| Enrollment | 35 participants |
| Start Date | 2026-06-01 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 35 participants in total. It began in 2026-06-01 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study aims to establish international consensus-based quality criteria for contrast-enhanced ultrasound (CEUS) examinations of the liver and to develop a standardized tool for assessing CEUS image quality. CEUS is an established imaging technique used in clinical practice for the characterization and assessment of focal liver lesions and other liver abnormalities. Despite its increasing use, there are currently no universally accepted or validated standards for evaluating the quality and reproducibility of CEUS examinations. The primary objective of this project is therefore to identify robust and clinically relevant quality indicators for liver CEUS examinations through an international Delphi consensus process. The study focuses specifically on CEUS examinations performed in adult patients using the ultrasound contrast agent SonoVue®. The project is divided into two work packages (WP). In Work Package 1 (WP1), the study team will first conduct a structured review of the available literature and discuss potential CEUS quality criteria within the research group. Based on this process, an initial catalogue of quality indicators relating to technical, procedural, and imaging characteristics relevant to liver CEUS examinations will be developed. These proposed criteria will subsequently be evaluated through a multi-round Delphi process involving an international and interdisciplinary panel of experienced CEUS users and experts. A minimum of 20 panellists will participate across all Delphi rounds. Participants will rate their level of agreement with each proposed quality criterion using a 7-point Likert scale and may suggest additional criteria where appropriate. Newly proposed criteria supported by more than 10% of participants will be included in subsequent Delphi rounds. During each round, panellists will receive anonymised feedback summarising the responses of the group and will be invited to re-evaluate the relevance of the proposed criteria. This iterative process will continue for at least three rounds or until predefined consensus criteria are achieved. Consensus will be defined as at least 70% agreement with a rating of 6 or higher on the Likert scale. In Work Package 2 (WP2), the consensus-based quality criteria identified in WP1 will be operationalised into a comprehensive and standardized rating scale for CEUS image quality assessment. Individual criteria will be grouped into broader domains and transformed into practical assessment items and prompts. The resulting rating tool will then be circulated among all Delphi panel members for final review and feedback to ensure clarity, applicability, and international usability. The overall goal of this study is to improve standardization, quality assurance, and reproducibility in liver CEUS examinations. The developed consensus criteria and rating scale may support clinical practice, future research studies, multicentre collaborations, and educational initiatives by enabling more consistent evaluation of CEUS image quality across institutions and countries.
Eligibility Criteria
Inclusion Criteria: * At least 6 years of active experience in ultrasound diagnostics in internal medicine, radiology, or a related clinical field * Independent performance of at least 5,000 ultrasound examinations Participation in structured CEUS training * Performance of at least 800 ultrasound examinations per year in routine clinical practice * Either: at least 100 independently performed CEUS examinations per year or more than 700 CEUS examinations in total * Regular participation in ultrasound-related meetings, case reviews, or quality assurance activities within their institution * Scientific involvement in CEUS, demonstrated by at least one peer-reviewed publication and/or active engagement in CEUS education or training * Signing the consent form of the participants Exclusion Criteria: * Failure to meet the inclusion criteria
Contact & Investigator
Robin Walter
STUDY CHAIR
University of Bern
Frequently Asked Questions
Who can join the NCT07656181 clinical trial?
This trial is open to participants of all sexes, studying Contrast Enhanced Ultrasound. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07656181 currently recruiting?
Yes, NCT07656181 is actively recruiting participants. Contact the research team at robin.walter@unibe.ch for enrollment information.
Where is the NCT07656181 trial being conducted?
This trial is being conducted at Bern, Switzerland.
Who is sponsoring the NCT07656181 clinical trial?
NCT07656181 is sponsored by University of Bern. The principal investigator is Robin Walter at University of Bern. The trial plans to enroll 35 participants.