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Diagnostic Efficacies of Sonazoid-CEUS and EOB-MRI in Patients With High Risk of HCC

NCT ID: NCT04212273

Last Updated: 2022-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-21

Study Completion Date

2022-12-24

Brief Summary

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Hepatocellular carcinoma (HCC) is the fifth most common cancer. Patients with HCCs usually have a poor prognosis. Hepatocarcinogenesis is an intricate and multistep process. Detecting and staging early HCC in patients with liver cirrhosis are still challenging for imaging techniques. Contrast-enhanced ultrasonography (CEUS) and gadoxetic acid-enhanced magnetic resonance imaging (EOB-MRI) are widely used in clinical practice. EOB-MRI has advantages of high detecting rate for small lesions, high sensitivity of hepatobiliary phase and extensive image information. Sonazoid has the advantage of offering a unique post-vascular phase, also called the Kupffer phase. Therefore, malignant tumors with few or no Kupffer cells appear as contrast defects, with respect to the relatively well-enhanced surrounding liver in the postvascular phase. The diagnostic efficacies of these two imaging methods have not been well studied. Therefore, the purpose of this study is to compare the efficacies of Sonazoid-CEUS and EOB-MRI in patients with high risk of HCC, and to compare the detection ability for malignant tumors by Kupffer phase and hepatobiliary phase.

Detailed Description

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Conditions

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Hepatocellular Cancer Liver Cirrhoses Diagnoses Disease

Keywords

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Hepatocellular carcinoma Sonazoid Contrast-enhanced ultrasound EOB-MRI Diagnostic Efficacy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diagnostic Sonazoid-CEUS and EOB-MRI

Patients with high risk of HCC having suspicious lesions on US will receive Sonazoid-CEUS and EOB-MRI examinations.

Group Type EXPERIMENTAL

Diagnostic Sonazoid-CEUS and EOB-MRI

Intervention Type DIAGNOSTIC_TEST

Undergo Sonazoid-CEUS and EOB-MRI

Interventions

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Diagnostic Sonazoid-CEUS and EOB-MRI

Undergo Sonazoid-CEUS and EOB-MRI

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Patients are at high risk for HCC.
2. The ages of patients are between 18 and 80.
3. Patients are with solid liver lesion(s) detected by US: if a patient has a solitary tumor, the size of the tumor is less than or equal to 5 cm; if a patient has multiple lesions, the sizes of the tumors are less than or equal to 3 cm and the number of lesions is less than or equal to 3.
4. Patient is able and willing to receive CEUS and EOB-MRI examinations within 30 days.
5. Patient signs the informed consent. -

Exclusion Criteria

1. Patient is with lesions confirmed by pathology or follow-up, or hemangiomas.
2. Patient is with lesions already undergoing local treatment, including thermal ablation or TACE.
3. Patient is with severe cardiopulmonary insufficiency.
4. Patient is a pregnant or breastfeeding women.
5. Patient is considered to be unsuitable to participate in the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tianjin Third Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xiang Jing, MD

Role: STUDY_DIRECTOR

Tianjin Third Central Hospital

Locations

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Tianjin Third Central Hospital

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiang Jing, MD

Role: CONTACT

Phone: 02284112323

Email: [email protected]

Yan Zhou

Role: CONTACT

Phone: 02284118101

Email: [email protected]

Facility Contacts

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Xiang Jing, MD

Role: primary

References

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European Association for the Study of the Liver. Corrigendum to "EASL Clinical Practice Guidelines: Management of hepatocellular carcinoma" [J Hepatol 69 (2018) 182-236]. J Hepatol. 2019 Apr;70(4):817. doi: 10.1016/j.jhep.2019.01.020. Epub 2019 Feb 7. No abstract available.

Reference Type BACKGROUND
PMID: 30739718 (View on PubMed)

Omata M, Cheng AL, Kokudo N, Kudo M, Lee JM, Jia J, Tateishi R, Han KH, Chawla YK, Shiina S, Jafri W, Payawal DA, Ohki T, Ogasawara S, Chen PJ, Lesmana CRA, Lesmana LA, Gani RA, Obi S, Dokmeci AK, Sarin SK. Asia-Pacific clinical practice guidelines on the management of hepatocellular carcinoma: a 2017 update. Hepatol Int. 2017 Jul;11(4):317-370. doi: 10.1007/s12072-017-9799-9. Epub 2017 Jun 15.

Reference Type BACKGROUND
PMID: 28620797 (View on PubMed)

Related Links

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https://linkinghub.elsevier.com/retrieve/pii/S0168-8278(19)30034-0

HCC diagnosis guideline

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5491694/

HCC diagnosis guideline

https://link.springer.com/article/10.1007/s00330-010-2030-1

EOB-MRI

Other Identifiers

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drjingxiang001

Identifier Type: -

Identifier Source: org_study_id