UNKNOWNNA

Role of CEUS as a Secondary Diagnostic Modality

To determine the role of contrast-enhanced ultrasound (CEUS) as a second-line imaging modality after gadoxetate-enhanced MRI (Gd-EOB-MRI) for identifying hepatocellular carcinoma (HCC) among at-risks observations.

Sponsor

Seoul National University Hospital

Enrollment

120 participants

Sites

1 locations

Start Date

June 2020

Completion

June 2021

Hepatocellular Carcinomacontrast enhanced ultrasound

Enrollment & Timeline

UNKNOWN

Target enrollment (estimated)

Target N

120

participants

Sites

locations

Duration

18 months

total trial span

Rate

pts/month needed

Jun 2020Month 76 of 18Jun 2021

100% of trial timeline elapsed

At 1 sites, each site needs to enroll approximately 7.0 patients/month to hit the enrollment target on schedule.

Enrollment target is estimated. ClinicalTrials.gov does not provide real-time enrollment progress.

View on ClinicalTrials.gov

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Primary Outcomes

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Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

No linked publications found in PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

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Fetching protocol from ClinicalTrials.gov…

UNKNOWNNA

Role of CEUS as a Secondary Diagnostic Modality

Sponsor

Seoul National University Hospital

Enrollment

120 participants

Sites

1 locations

Start Date

June 2020

Completion

June 2021

Hepatocellular Carcinomacontrast enhanced ultrasound

Enrollment & Timeline

UNKNOWN

Target enrollment (estimated)

Target N

120

participants

Sites

locations

Duration

18 months

total trial span

Rate

pts/month needed

Jun 2020Month 76 of 18Jun 2021

100% of trial timeline elapsed

At 1 sites, each site needs to enroll approximately 7.0 patients/month to hit the enrollment target on schedule.

Enrollment target is estimated. ClinicalTrials.gov does not provide real-time enrollment progress.

View on ClinicalTrials.gov

Ask AI

Primary Outcomes

Ask AI

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

No linked publications found in PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

Ask AI

Compared the image features of CEUS and Gd-EOB-MRI in at-risk observation

1. For 3 days after undergoing CEUS to check the complication of CEUS, per each participants. 2. The time interval between CEUS and Gd-EOB-MRI should not be exceed 4 weeks.

Compared the frequency of arterial phase hyperenhancement (APHE) and washout in at-risk observation, between CEUS and Gd-EOB-MRI.

Compared diagnostic performance of Gd-EOB-MRI alone and Gd-EOB-MRI with CEUS.

1. For 3 days after undergoing CEUS to check the complication of CEUS, per each participants. 2. The time interval between CEUS and Gd-EOB-MRI should not be exceed 4 weeks.

Evaluated sensitivity, specificity and accuracy for diagnose HCC by using Gd-EOB-MRI alone, or Gd-EOB-MRI with CEUS.

Eligibility

Min Age

18 Years

Sex

all

Healthy Volunteers

Yes

View full criteria

Inclusion Criteria:

* at risk of HCC by Liver Imaging Reporting and Data System (LI-RADS)
* at least one treatment-naïve solid hepatic observation (≥1 cm) while surveillance using US, CT or MRI
* signed informed consent

Exclusion Criteria:

* congestive hepatopathies
* severe cardiovascular dysfunction
* no recent cross-sectional images within 4 weeks
* suboptimal cross-sectional images quality

Ask AI

Role of CEUS as a Secondary Diagnostic Modality

Enrollment & Timeline

Primary Outcomes

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Role of CEUS as a Secondary Diagnostic Modality

Enrollment & Timeline

Primary Outcomes

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Eligibility

Trial Sites (1)