CT Perfusion Parameters for Advanced HCC Treated by Systemic Immunotherapy

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05580809

Enrollment

Registered

2022-10-14

Start date

2021-08-01

Completion date

2022-08-30

Last updated

2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced HCC Treated by Systemic Immunotherapy

Brief summary

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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

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

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

Countries

France

Outcome results