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

Hepatocellular Carcinoma Clinical Trial

— DCE-MRI  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01806740
• Other study ID #: DGD-44-057
• Status: Terminated
• Phase: Phase 4
• Start date: May 9, 2013
• Est. completion date: October 12, 2015

Study information

• Verified date: June 2019
• Source: Guerbet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 37
• Est. completion date: October 12, 2015
• Est. primary completion date: October 12, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Gadoterate meglumine
Gadoterate meglumine was administered at a dose of 0.1 mmol/kg (0.2 mL/kg) using a power injector, in an intravenous bolus at a rate of 3 mL/sec.

Locations

Country	Name	City	State
Korea, Republic of	Guerbet Korea	Seoul	Gangnam Gu

Sponsors (1)

Lead Sponsor	Collaborator
Guerbet

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation Coefficient Between DCE-MRI Perfusion Parameters and the Response of Target Lesions to Sorafenib	To evaluate the correlation between DCE-MRI perfusion parameters (Ktrans, AUC, ve, kep, T1, Wash-in, Washout) at baseline, week 1 and week 2, and the response of target lesions to sorafenib.; Ktrans: volume transfer constant between blood plasma and extravascular extracellular space; AUC : area under the curve of tissue gadolinium concentration-time; ve: fractional volume of extravascular extracellular space; kep: rate constant between extravascular extracellular space and blood plasma (=Ktrans/ve); T1: longitudinal relaxation time; Wash-in: slope of the early enhancement curve; Washout: slope of the late enhancement curve; The response of target lesions was assessed by mRECIST at 2 months after initiation of treatment (sorafenib).; The correlation analyses were done using Pearson or Spearman correlation coefficient.	3 months
Secondary	Correlation Coefficient Between DCE-MRI Perfusion Parameters at Baseline and Overall Survival	To evaluate the correlation between DCE-MRI perfusion parameters (Ktrans, AUC, ve, kep, T1, wash-in, washout) at baseline and overall survival.; The overall survival was calculated from the patient's survival status recorded one year after initiation of the sorafenib treatment.; The correlation analyses were done using Pearson or Spearman correlation coefficient.	1 year
Secondary	Correlation Coefficient Between DCE-MRI Perfusion Parameters at Baseline and Progression Free Survival	To evaluate the correlation between DCE-MRI perfusion parameters (Ktrans, AUC, ve, kep, T1, wash-in, washout) at baseline and progression free survival.; The progression free survival was calculated from the patient's survival status and tumor progression status recorded one year after initiation of the sorafenib treatment.; The correlation analyses were done using Pearson or Spearman correlation coefficient.	1 year
Secondary	Correlation Coefficient Between DCE-MRI Perfusion Parameters at Baseline and Time to Progression	To evaluate the correlation between DCE-MRI perfusion parameters (Ktrans, AUC, ve, kep, T1, wash-in, washout) at baseline and time to progression.; The time to progression was calculated from the patient's survival status and tumor progression status recorded one year after initiation of the sorafenib treatment.; The correlation analyses were done using Pearson or Spearman correlation coefficient.	1 year