NCT06876805

Brief Summary

The primary objective of the study is to determine the accuracy of CEUS in characterizing (as benign or malignant) focal liver lesions for which CT, MRI and/or PET have not been conclusive.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
10mo left

Started Aug 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress66%
Aug 2024Apr 2027

Study Start

First participant enrolled

August 1, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 14, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

March 14, 2025

Status Verified

March 1, 2025

Enrollment Period

2 years

First QC Date

March 10, 2025

Last Update Submit

March 10, 2025

Conditions

Focal Liver Lesion

Keywords

CEUSUltrasoundLiverHCC

Outcome Measures

Primary Outcomes (1)

  • CEUS diagnostic accuracy

    CEUS diagnostic accuracy in determining the nature of focal liver lesions

    2 years

Study Arms (1)

Group 1

Patients with focal liver lesions indeterminated at II level imaging methods

Diagnostic Test: CEUS or Contrast enhanced Ultrasound

Interventions

CEUS or Contrast enhanced UltrasoundDIAGNOSTIC_TEST

CEUS performed as normal clinical practice

Also known as: Contrast enhanced ultrasound
Group 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients who have previously resulted positive to CT, MRI and/or PET scans for liver lesions but with no information on the nature of the lesion and that will undero CEUS for further characterization of the lesion(s) will be consecutively enrolled.

You may qualify if:

  • Age ≥18 years.
  • CEUS performed performed in the last 6 months a CT, MRI and/or PET not decisive in characterizing a liver lesion.
  • Obtaining informed consent.

You may not qualify if:

  • Technical impossibility to perform the ultrasound evaluation.
  • Documented allergy to the ultrasound contrast medium.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Policlinico Sant'Orsola Malpighi

Bologna, 40138, Italy

RECRUITING

Study Officials

  • Carla Serra, PhD

    IRCCS Azienda Ospedaliero-Universitaria di Bologna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carla Serra, PhD

CONTACT

+390512143270carla.serra@aosp.bo.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2025

First Posted

March 14, 2025

Study Start

August 1, 2024

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

April 1, 2027

Last Updated

March 14, 2025

Record last verified: 2025-03

Locations

IT(1)