CT Perfusion Parameters for Advanced HCC Treated by Systemic Immunotherapy

NCT ID: NCT05580809

Last Updated: 2022-10-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 9 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2022-08-30

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

Conditions

Advanced HCC Treated by Systemic Immunotherapy

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Valérie LAURENT

OTHER

Sponsor Role: lead

Responsible Party

Valérie LAURENT

MD, PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

CHRU Nancy

Nancy, , France

Countries

France

Other Identifiers

2022PI117

Identifier Type: -

Identifier Source: org_study_id