Follow up After TACE by Elastography and Color Doppler.

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06070623
Collaborator
(none)
54
26

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: US

Detailed 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 , hepatic artery resistive index and hepatic artery pulsitality index .

Study Design

Study Type:
Observational
Anticipated Enrollment :
54 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Role of Sonograpic Evaluation Via Doppler and Elastography in Evaluation of Hepatic Neoplasms Post TACE With Correlation With Modified RECIST Criteria.
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Nov 30, 2025
Anticipated Study Completion Date :
Dec 31, 2025

Outcome Measures

Primary Outcome Measures

  1. Role of elastography and color Doppler to follow up after TACE. [Baseline]

    Accuracy of elastography and color Doppler in follow up of patients with HCC who underwent TACE, compared to modified RECIST criteria.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

  • Study Director: Mostafa Thabet, Prof Dr, Professor doctor at radiology department - Assiut University
  • Study Director: Haysam Samy, Prof Dr, Professor doctor at radiology department - South Egypt cancer institute
  • Study Director: Mohamed Elbaroudy, Ass. Prof Dr, Assistant professor doctor at radiology department - South Egypt cancer institute

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Marco Moheb Samaan Drota, Dr at diagnostic and interventional radiology department - South Egypt cancer institute, Assiut University
ClinicalTrials.gov Identifier:
NCT06070623
Other Study ID Numbers:
  • Elastography, Doppler in TACE.
First Posted:
Oct 6, 2023
Last Update Posted:
Oct 6, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Marco Moheb Samaan Drota, Dr at diagnostic and interventional radiology department - South Egypt cancer institute, Assiut University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 6, 2023