CT Perfusion Parameters for Advanced HCC Treated by Systemic Immunotherapy

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

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

Study Overview

• Status: Completed
• Conditions: Advanced HCC Treated by Systemic Immunotherapy

• Study Type: Observational
• Enrollment (Actual): 9

Contacts and Locations

Study Locations

• France
  • Nancy, France, 54000
    • CHRU Nancy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

HepatoCellular Carcinoma (HCC) treated by systemic immunotherapy

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of CT perfusion parameters between the responders and non-responders according to RECIST 1.1 assessment for advanced HCC treated by systemic immunotherapy	Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 assessed by a senior radiologist. Comparison assessed by t test or Mann-Whitney test.	Through study completion, an average of 1 year
Comparison of CT perfusion parameters between the responders and non-responders according to mRECIST assessment for advanced HCC treated by systemic immunotherapy	modified Response Evaluation Criteria in Solid Tumors (mRECIST) assessed by a senior radiologist. Comparison assessed by t test or Mann-Whitney test.	Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of CT perfusion parameters as predictive factors of response on baseline and on early follow-up	Assessed using logistic regression	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Valérie LAURENT

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): August 30, 2022

Study Registration Dates

• First Submitted: October 7, 2022
• First Submitted That Met QC Criteria: October 11, 2022
• First Posted (Actual): October 14, 2022

Study Record Updates

• Last Update Posted (Actual): October 17, 2022
• Last Update Submitted That Met QC Criteria: October 13, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2022PI117

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No