Follow up After TACE by Elastography and Color Doppler.

Hepatocellular Carcinoma Clinical Trial

Official title:

Role of Sonograpic Evaluation Via Doppler and Elastography in Evaluation of Hepatic Neoplasms Post TACE With Correlation With Modified RECIST Criteria.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06070623
• Other study ID #: Elastography, Doppler in TACE.
• Status: Not yet recruiting
• Start date: November 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: October 2023
• Source: Assiut University
• Contact: Marco Drota, Radiologist
• Phone: +201060134725
• Email: marco.moheb279[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To determine accuracy of elastography and color Doppler in follow up of patients with HCC after TACE comparing with modified RECIST criteria.

Description:

The incidence of liver cancer is one of the highest in the world. In Egypt HCC is the forth common cancer and represents up to 90% of all liver malignancies. Where it is responsible for 33.63% and 13.54% of all cancers in males and females respectively.

Transarterial chemoembolization (TACE) is recommended as the first-line treatment in early stage patients with hepatocellular carcinoma (HCC) or as a palliative treatment modality in advanced patients with unresctable tumor which was known to increase survival rate. However, tumor control usually requires multiple TACE interventions due to the presence of residual and recurrent lesions.

Currently the Response Evaluation Criteria in Solid Tumors (RECIST) guideline was proposed as a method for measuring treatment response based on tumor shrinkage, which is a valuable measure of antitumor activity of cytotoxic drugs, Which adapted the concept of viable tumor-tumoral tissue showing uptake in arterial phase of contrast-enhanced MSCT abdomen.

Elastography can provide information about tumor stiffness to predict tumor response after TACE and detect any residual or recurrence.

We also use color Doppler in follow up to detect changes in portal pressure and hepatic artries hemodynamics of HCC patients after TACE. Mainly we search for changes in portal vein velocity {PVVel}, hepatic artery resistive index {HARI} and hepatic artery pulsitality index {HAPI}.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 54
• Est. completion date: December 31, 2025
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All patients with hepatocellular carcinoma underwent TACE in South Egypt cancer institute.

Exclusion Criteria:

• Patients with liver metastases.

• Patients with hepatic or perihepatic inflammations.

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Device:
• US
We use elastography and color Doppler from US machine and compare results with CT

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (4)

Conti CB, Cavalcoli F, Fraquelli M, Conte D, Massironi S. Ultrasound elastographic techniques in focal liver lesions. World J Gastroenterol. 2016 Mar 7;22(9):2647-56. doi: 10.3748/wjg.v22.i9.2647. — View Citation

Hou S, Hua S, Cui K, Liu F, Ding K, Yuan J. The course and prognostic value of tumor stiffness detected by ultrasound elastography for transarterial chemoembolization of hepatocellular carcinoma. Quant Imaging Med Surg. 2023 Jun 1;13(6):3962-3972. doi: 10.21037/qims-22-292. Epub 2023 May 9. — View Citation

Sato Y, Watanabe H, Sone M, Onaya H, Sakamoto N, Osuga K, Takahashi M, Arai Y; Japan Interventional Radiology in Oncology Study Group-JIVROSG. Tumor response evaluation criteria for HCC (hepatocellular carcinoma) treated using TACE (transcatheter arterial chemoembolization): RECIST (response evaluation criteria in solid tumors) version 1.1 and mRECIST (modified RECIST): JIVROSG-0602. Ups J Med Sci. 2013 Mar;118(1):16-22. doi: 10.3109/03009734.2012.729104. Epub 2012 Nov 20. — View Citation

Tierney J, Baker J, Borgmann A, Brown D, Byram B. Non-contrast power Doppler ultrasound imaging for early assessment of trans-arterial chemoembolization of liver tumors. Sci Rep. 2019 Sep 10;9(1):13020. doi: 10.1038/s41598-019-49448-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Role of elastography and color Doppler to follow up after TACE.	Accuracy of elastography and color Doppler in follow up of patients with HCC who underwent TACE, compared to modified RECIST criteria.	Baseline