NCT06070623

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2023

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 6, 2023

Completed
26 days until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

October 6, 2023

Status Verified

October 1, 2023

Enrollment Period

2.1 years

First QC Date

October 2, 2023

Last Update Submit

October 2, 2023

Conditions

Keywords

TACE

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

USDEVICE

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

Also known as: CT

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with hepatic focal lesion , which is eligable to trans arterial chemoebmolization.

You may qualify if:

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

You may not qualify if:

  • Patients with liver metastases.
  • Patients with hepatic or perihepatic inflammations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 31506503BACKGROUND
  • 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.

    PMID: 23167460BACKGROUND
  • 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.

    PMID: 37284088BACKGROUND
  • 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.

    PMID: 26973405BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • 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 DIRECTOR

Central Study Contacts

Marco Drota, Radiologist

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr at diagnostic and interventional radiology department - South Egypt cancer institute

Study Record Dates

First Submitted

October 2, 2023

First Posted

October 6, 2023

Study Start

November 1, 2023

Primary Completion

November 30, 2025

Study Completion

December 31, 2025

Last Updated

October 6, 2023

Record last verified: 2023-10