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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06168357
Other study ID # Role of MRI in HCC
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 2024
Est. completion date September 30, 2027

Study information

Verified date November 2023
Source Assiut University
Contact Nour Mokhles Farah, Resident doctor
Phone 01212872901
Email Nmokhles492@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Role of ADC value and DWI in abbreviated MRI compared to post-contrast CT in follow-up of HCC after TACE.


Description:

Hepatocellular carcinoma (HCC) is the 5th most common cancer in the world and the most common in Egypt . Trans-arterial chemoembolization (TACE) is the treatment recommended for unresectable HCC according to Barcelona clinic liver cancer staging and is widely used . HCC is nourished only by the hepatic artery, so TACE causes ischemia and coagulative necrosis. However; viable neoplastic tissue residual may be seen after TACE. Assessment of post-TACE tumor response is important in determining treatment success and in guiding future therapy . Many studies have assessed the diagnostic performance of multiphasic contrast-enhanced computed tomography (CT) and magnetic resonance imaging (MRI) in diagnosis of HCC with noted higher sensitivity of MRI compared to CT. CT or MRI are recommended for assessment of response after treatment as well . Diffusion-weighted imaging (DWI) and apparent diffusion coefficient (ADC) are functional MRI techniques that detect signal changes in tissues due to water proton motion. The intact membranes of viable tumor cells restrict water diffusion, whereas necrotic tumor cells with disrupted cell membranes exhibit increased water diffusion and which differentiate the biological activity of HCC


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 55
Est. completion date September 30, 2027
Est. primary completion date September 30, 2025
Accepts healthy volunteers
Gender All
Age group 20 Years to 85 Years
Eligibility Inclusion Criteria: - Patients who underwent TACE for unresectable HCC with patent portal vein based on Doppler, no ascites, and satisfactory liver function. Age between 20-year old and 85-year old Exclusion Criteria: - Estimated GFR less than 60 Previous history of severe allergic reaction to the iodinated contrast agent Patients with claustrophobia who can't undergo MR examination. Patients having cochlear implants or cardiac pacemaker

Study Design


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (7)

European Association for the Study of the Liver. Electronic address: easloffice@easloffice.eu; European Association for the Study of the Liver. EASL Clinical Practice Guidelines: Management of hepatocellular carcinoma. J Hepatol. 2018 Jul;69(1):182-236. d — View Citation

Gluskin JS, Chegai F, Monti S, Squillaci E, Mannelli L. Hepatocellular Carcinoma and Diffusion-Weighted MRI: Detection and Evaluation of Treatment Response. J Cancer. 2016 Jul 13;7(11):1565-70. doi: 10.7150/jca.14582. eCollection 2016. — View Citation

Liu Z, Fan JM, He C, Li ZF, Xu YS, Li Z, Liu HF, Lei JQ. Utility of diffusion weighted imaging with the quantitative apparent diffusion coefficient in diagnosing residual or recurrent hepatocellular carcinoma after transarterial chemoembolization: a meta- — View Citation

Ludwig JM, Camacho JC, Kokabi N, Xing M, Kim HS. The Role of Diffusion-Weighted Imaging (DWI) in Locoregional Therapy Outcome Prediction and Response Assessment for Hepatocellular Carcinoma (HCC): The New Era of Functional Imaging Biomarkers. Diagnostics — View Citation

Sung PS, Choi MH, Yang H, Lee SK, Chun HJ, Jang JW, Choi JY, Yoon SK, Choi JI, Lee YJ, Bae SH. Diffusion-Weighted Magnetic Resonance Imaging in Hepatocellular Carcinoma as a Predictor of a Response to Cisplatin-Based Hepatic Arterial Infusion Chemotherapy — View Citation

Surov A, Pech M, Omari J, Fischbach F, Damm R, Fischbach K, Powerski M, Relja B, Wienke A. Diffusion-Weighted Imaging Reflects Tumor Grading and Microvascular Invasion in Hepatocellular Carcinoma. Liver Cancer. 2021 Feb;10(1):10-24. doi: 10.1159/000511384 — View Citation

Wang WT, Yang L, Yang ZX, Hu XX, Ding Y, Yan X, Fu CX, Grimm R, Zeng MS, Rao SX. Assessment of Microvascular Invasion of Hepatocellular Carcinoma with Diffusion Kurtosis Imaging. Radiology. 2018 Feb;286(2):571-580. doi: 10.1148/radiol.2017170515. Epub 201 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Correlation between tumor enhancement in arterial phase expressed as Hounsfield unit number and ADC value. correlation between tumor enhancement in arterial phase expressed as Hounsfield unit number and ADC value. Baseline
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