Added Value in Combined Use of Fusion Imaging and Contrast-enhanced Ultrasonography

NCT ID: NCT04487288

Last Updated: 2021-04-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-02
• Study Completion Date: 2022-12-30

Brief Summary

So far, there have been studies showing that the CEUS-grafted technique has added value in biopsy and RFA, but no studies have compared the group using only fusion and the group using CEUS+fusion. Therefore, the additional added value of CEUS will be evaluated by comparing the two groups.

Detailed Description

Despite the rapid development of tumor markers and liver imaging, pathological confirmation is still necessary for atypical liver lesions that do not meet imaging criteria. US guided procedures are widely used as a method to identify focal lesions of the liver pathologically, and these US guided procedures have no burden on the operation, can be easily accessed, and have a lower cost than surgery. However, the frequency of pathological confirmation with this US guided procedure remains at around 90%. In order to increase this probability, a technique for fusion of liver CT/MRI and US has been widely used in recent years, and this allows accurate targeting of small lesions through structures seen in CT and MR. Through the fusion technique, the biopsy success rate for focal lesions can be increased to 94.4%. However, there are many cases where lesions deeply located in patients with cirrhosis are invisible, and biopsy is difficult only with fusion due to poor sonic window in patients with high BMI. To this end, a technique called contrast-enhanced ultrasonography (CEUS), such as the fusion technique, was added, which is a technique that can identify tumor vascularity in real-time using second-generation contrast media. In recent studies, there are studies combining this fusion technique and CEUS technique, and the success rate of these techniques varies from 87.6% to 97.5%. Although CEUS with fusion techniques are theoretically superior to fusion only technique, the use of CEUS adds cost of contrast media and is limited in patients with side effects on contrast media. . Also, there is no study comparing the two so far, and this study intends to compare the technique combining CEUS and fusion and the technique using only fusion.

Conditions

Contrast Media, Liver, Biopsy, Fusion

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

CEUS with fusion

Control group: The historic cohort is used to compare the results of the biopsy using fusion only technique from 2013 to 2019.

Group Type: EXPERIMENTAL

SONAZOID

Intervention Type: DIAGNOSTIC_TEST

CEUS using SONAZOID with fusion technique

Interventions

SONAZOID

CEUS using SONAZOID with fusion technique

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Patients scheduled for ultrasound biopsy to confirm local liver lesions
• Adults over 18
• Patients who underwent multi-phasic liver CT or MRI within 6 weeks prior to the procedure
• Patients who understand and agree to the explanation and consent form and submit the consent form

Exclusion Criteria

• Non-adaptive patients with ultrasound contrast agents (eg acute respiratory failure, heart disease, egg allergy, pregnant women, lactating women)
• Those who have difficulty obtaining proper liver ultrasound images A. Patient cooperation is not possible B. If it is difficult to obtain an image that is appropriate for the researcher's judgment (atrophy of the right lobe of the liver, a bowel is located between the liver and the abdominal wall, etc.)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Korean Liver Cancer Association

UNKNOWN

Sponsor Role: collaborator

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jeong Min Lee

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeong Min Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital, Radiology department

Locations

Seoul National University Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

SAE JIN PARK, MD

Role: CONTACT

psjko05@gmail.com

+82-2072-3107 ext. 3107

Other Identifiers

H-2003-044-1108

Identifier Type: -

Identifier Source: org_study_id