Focal Liver LesionInFoLILNCT06876805
The Role of Ceus in the Characterization of Focal Liver Lesions Indeterminate to Second-level Methods
An observational study of Focal Liver Lesion, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Focal Liver Lesion
- What is being tested?
- CEUS or Contrast enhanced Ultrasound
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Aug 2024to 1 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: 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.
Who may be able to join
- 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.
Who cannot join
- Technical impossibility to perform the ultrasound evaluation.
- Documented allergy to the ultrasound contrast medium.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Policlinico Sant'Orsola Malpighi
Bologna, 40138
Carla Serra, PhD, +390512143270, carla.serra@aosp.bo.it
About this study
Official title: The Role of Contrast Enhanced Ultrasond (Ceus), in the Characterization of Focal Liver Lesions Indeterminate to Second-level Methods
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.
Read the detailed description
The study conducted will be a non-profit, observational, non-pharmacological, cross-sectional, but also partly cohort, retrospective and prospective study. The study is cross-sectional in nature, but will require 6 months of follow-up to evaluate the gold standard reference outcome in patients diagnosed with a benign pathology that does not require further investigations, and in patients with suspected malignant lesion for which histological diagnosis has not been performed on biopsy.
- Conditions
- Focal Liver Lesion
- Being tested
- CEUS or Contrast enhanced Ultrasound
- Keywords
- CEUS, Ultrasound, Liver, HCC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CEUS or Contrast enhanced UltrasoundDiagnostic test
Also called Contrast enhanced ultrasound
CEUS performed as normal clinical practice
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients with focal liver lesions indeterminated at II level imaging methods Receives: Diagnostic Test: CEUS or Contrast enhanced Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
CEUS diagnostic accuracy
CEUS diagnostic accuracy in determining the nature of focal liver lesions
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start1 Aug 2024
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focal Liver LesionStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carla Serra, PhD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06876805
- Sponsor's protocol ID
- InFoLIL
- Acronym
- InFoLIL
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2025
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Contrast Enhanced Ultrasond (Ceus), in the Characterization of Focal Liver Lesions Indeterminate to Second-level Methods
- ClinicalTrials.gov ID
- NCT06876805
- Acronym / sponsor ID
- InFoLIL / InFoLIL
- Conditions
- Focal Liver Lesion
- Keywords
- CEUS, Ultrasound, Liver, HCC
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 14 Mar 2025 (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.
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.
Detailed description
The study conducted will be a non-profit, observational, non-pharmacological, cross-sectional, but also partly cohort, retrospective and prospective study. The study is cross-sectional in nature, but will require 6 months of follow-up to evaluate the gold standard reference outcome in patients diagnosed with a benign pathology that does not require further investigations, and in patients with suspected malignant lesion for which histological diagnosis has not been performed on biopsy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Diagnostic Test: CEUS or Contrast enhanced UltrasoundPatients with focal liver lesions indeterminated at II level imaging methods |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Technical impossibility to perform the ultrasound evaluation.
- Documented allergy to the ultrasound contrast medium.
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 |
|---|---|---|
| CEUS or Contrast enhanced UltrasoundAlso: Contrast enhanced ultrasoundCEUS performed as normal clinical practice | Diagnostic test | Group 1 |
Primary outcome
CEUS diagnostic accuracy
Time frame: 2 years
CEUS diagnostic accuracy in determining the nature of focal liver lesions
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
Carla Serra, PhD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
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 Focal Liver Lesion, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 14 Mar 2025. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carla Serra, PhD (+390512143270, carla.serra@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CEUS diagnostic accuracy (time frame: 2 years). 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 14 Mar 2025.