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CT Perfusion Parameters for Advanced HCC Treated by Systemic Immunotherapy

Sponsor
Valérie LAURENT (Other)
Overall Status
Completed
CT.gov ID
NCT05580809
Collaborator
(none)
9
Enrollment
1
Location
12.9
Actual Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    9 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    CT Perfusion Parameters for Advanced HCC Treated by Systemic Immunotherapy : a Pilot Study
    Actual Study Start Date :
    Aug 1, 2021
    Actual Primary Completion Date :
    Jun 30, 2022
    Actual Study Completion Date :
    Aug 30, 2022

    Outcome Measures

    Primary Outcome Measures

    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 [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 [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 Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHRU Nancy Nancy France 54000

    Sponsors and Collaborators

    • Valérie LAURENT

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Valérie LAURENT, MD, PhD, Central Hospital, Nancy, France
    ClinicalTrials.gov Identifier:
    NCT05580809
    Other Study ID Numbers:
    • 2022PI117
    First Posted:
    Oct 14, 2022
    Last Update Posted:
    Oct 17, 2022
    Last Verified:
    Oct 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Oct 17, 2022