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

Primary Purpose

Hepatocellular Carcinoma

Status
Terminated
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Gadoterate meglumine
Sponsored by
Guerbet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hepatocellular Carcinoma focused on measuring DCE-MRI, Sorafenib response

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  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

Sites / Locations

  • Guerbet Korea

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gadoterate meglumine

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
November 6, 2012
Last Updated
June 24, 2019
Sponsor
Guerbet
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1. Study Identification

Unique Protocol Identification Number
NCT01806740
Brief Title
DCE-MRI Using Dotarem® in Evaluation of Therapeutic Response to Sorafenib in Patients With Advanced Stage HCC
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Terminated
Why Stopped
The planned number of enrolled patients was not reached.
Study Start Date
May 9, 2013 (Actual)
Primary Completion Date
October 12, 2015 (Actual)
Study Completion Date
October 12, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guerbet

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
DCE-MRI, Sorafenib response

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gadoterate meglumine
Arm Type
Experimental
Arm Description
there is one single arm of patients (no comparative arm)
Intervention Type
Drug
Intervention Name(s)
Gadoterate meglumine
Other Intervention Name(s)
gadoteric acid, Dotarem
Intervention Description
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.
Primary Outcome Measure Information:
Title
Correlation Coefficient Between DCE-MRI Perfusion Parameters and the Response of Target Lesions to Sorafenib
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Correlation Coefficient Between DCE-MRI Perfusion Parameters at Baseline and Overall Survival
Description
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.
Time Frame
1 year
Title
Correlation Coefficient Between DCE-MRI Perfusion Parameters at Baseline and Progression Free Survival
Description
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.
Time Frame
1 year
Title
Correlation Coefficient Between DCE-MRI Perfusion Parameters at Baseline and Time to Progression
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Male and female adult patients (age ≥ 20 years old) Patients diagnosed with unresectable HCC [Child Pugh class A and major vascular invasion, extrahapatic metastasis, or progression after transarterial chemoembolization more than 2 times] 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] Patients planned to be treated with sorafenib Patient with liver CT performed or planned to be performed within 4 weeks before initiation of sorafenib treatment Patient with a life expectancy of 12 weeks or more No previous treatment with sorafenib 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeong Min Lee, Ph.D
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guerbet Korea
City
Seoul
State/Province
Gangnam Gu
ZIP/Postal Code
135-920
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
It will be decided after study completion.

Learn more about this trial

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

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