DCE-MRI Using Dotarem® in Evaluation of Therapeutic Response to Sorafenib in Patients With Advanced Stage HCC

Guerbet

Status and phase: Terminated; Phase 4

Conditions: Hepatocellular Carcinoma

Treatments: Drug: Gadoterate meglumine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01806740

DGD-44-057

Details and patient eligibility

About

The main objective is to evaluate the value of dynamic contrast-enhanced Magnetic Resonance Imaging (DCE-MRI) in prediction of response of patients with hepatocellular carcinoma (HCC) to treatment with Sorafenib assessed by mRECIST.

Full description

One of the secondary objectives was to evaluate the correlation between DCE-MRI perfusion parameters at baseline and:

• Overall Survival (OS)
• Progression-Free Survival (PFS)
• Time to Progression (TTP)

Three DCE-MRI examinations were done during the study:

• at the enrolment and initiation of the sorafenib treatment
• one week after initiation of the sorafenib treatment
• two weeks after initiation of the sorafenib treatment

DCE-MRI perfusion parameters were assessed by a centralized radiologist at baseline (corresponding to the day of enrolment and initiation of Sorafenib treatment), week 1 and week 2.

According to mRECIST criteria, HCC lesions were evaluated on computed tomography images by two on-site radiologists at the time of enrolment and 8 weeks later (2 months). OS, PFS and TTP were calculated from survival and tumor progression data recorded one year after initiation of the sorafenib treatment.

Enrollment: 37 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

1. Male and female adult patients (age ≥ 20 years old)
2. Patients diagnosed with unresectable HCC [Child Pugh class A and major vascular invasion, extrahapatic metastasis, or progression after transarterial chemoembolization more than 2 times]
3. Presence of mRECIST target lesion within liver [lesion which can be classified as a RECIST measurable lesion (can be measured ≥ 1 cm in at least one dimension), lesion suitable for repeated measure, lesion showing intraluminal arterial enhancement on contrast-enhanced CT or MRI]
4. Patients planned to be treated with sorafenib
5. Patient with liver CT performed or planned to be performed within 4 weeks before initiation of sorafenib treatment
6. Patient with a life expectancy of 12 weeks or more
7. No previous treatment with sorafenib
8. Female patients who are surgically sterilized, or post-menopausal (minimum 12 months of amenorrhea) or who have a documented negative urine hCG test at screening

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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37 participants in 1 patient group

Gadoterate meglumine

Experimental group

Description:

there is one single arm of patients (no comparative arm)

Treatment:

Drug: Gadoterate meglumine