Skip to main content
OpenTrials
Completed

NCT Number: NCT05580809

CT Perfusion Parameters for Advanced HCC Treated by Systemic Immunotherapy

The purpose of this study is to compare CT perfusion parameters to RECIST 1.1 and mRECIST assessment for advanced HCC treated by systemic immunotherapy, and to evaluate perfusion parameters as predictive factors of response on baseline and on early follow-up

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Advanced HCC Treated by Systemic Immunotherapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU Nancy

Nancy, 54000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients > 18 years old
  • Proved HCC
  • Advanced HCC, defined as Barcelona Clinic Liver Classifications (BCLC) stage B non eligible for loco-regional therapy and stage C
  • No prior systemic therapy
  • Measurable disease per Response Evaluation Criteria for Solid Tumour (RECIST) v1.1
  • Child-Pugh Score = A
  • Eastern Cooperative Oncology Group (ECOG) Performance Status < 2

Exclusion criteria

  • Absence of CT perfusion before treatment initiation more than a two-month delay between treatment initiation and first post-treatment CT perfusion
  • Uninterpretable CT perfusion
  • Definitive contraindication to CT perfusion (allergy or advanced renal disease)

Treatment and study plan

Primary outcomes

  1. Comparison of CT perfusion parameters between the responders and non-responders according to RECIST 1.1 assessment for advanced HCC treated by systemic immunotherapy

    Time frame: Through study completion, an average of 1 year

    Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 assessed by a senior radiologist. Comparison assessed by t test or Mann-Whitney test.

  2. Comparison of CT perfusion parameters between the responders and non-responders according to mRECIST assessment for advanced HCC treated by systemic immunotherapy

    Time frame: Through study completion, an average of 1 year

    modified Response Evaluation Criteria in Solid Tumors (mRECIST) assessed by a senior radiologist. Comparison assessed by t test or Mann-Whitney test.

Secondary outcomes

  1. Evaluation of CT perfusion parameters as predictive factors of response on baseline and on early follow-up

    Time frame: Through study completion, an average of 1 year

    Assessed using logistic regression

Sponsors and collaborators

Lead sponsor

Valérie LAURENT

Other

Registry information

Official study title

CT Perfusion Parameters for Advanced HCC Treated by Systemic Immunotherapy : a Pilot Study

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 14, 2022
Registry last updated
Oct 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.