Know Cancer

or
forgot password

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


Phase 4
20 Years
N/A
Not Enrolling
Both
Hepatocellular Carcinoma

Thank you

Trial Information

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


Secondary objectives :

1. To evaluate the value of percent change of DCE-MRI/AFP/DWI from baseline to follow up
at 1 or 2 weeks in prediction of overall survival, progression-free survival, and time
to progression

2. To evaluate the value of baseline DCE-MRI/AFP/DWI in prediction of overall survival,
progression-free survival, and time to progression.


Inclusion Criteria:



1. Age ≥ 20 years old

2. Subject diagnosed for Unresectable HCC (Child Pugh class A and major vascular
invasion, extrahapatic metastasis, or progression after TACE more than 2 times).

3. Presence of mRECIST target lesion (Lesion which can be classified as a RECIST
measurable lesion(can be measured ≥ 1 cm in at least one dimension), Lesion suitable
for repeat measure, Lesion showing intraluminal arterial enhancement on
contrast-enhanced CT or MRI) within liver

4. Patient 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. Subjects able to understand and having provided written informed consent to
participate in the trial.

9. Female subjects who are surgically sterilized, or post-menopausal (minimum 12 months
of amenorrhea) or who have a documented negative urine hCG test at screening

Exclusion Criteria:

1. Contraindication to MRI (e.g. : severe claustrophobia, pacemaker, metalic joint
replacement or any other according to the imaging center's standard practice)

2. Subjects presenting with known severe renal failure (estimated creatinine clearance <
30 ml/min calculated by the Cockcroft-Gault formula or estimated GFR <
30ml/min/1.73m² by MDRD)

3. History of hypersensitivity reaction to a gadolinium contrast media

4. Female with child bearing potential without contraception using at least 2 different
methods

5. Breast feeding or pregnant female

6. Any condition which, based on the investigator's clinical judgment, would prevent the
patient from completing all trial assessments and visits (for example: mental or
physical incapacity, language comprehension, geographical localisation, etc…)

7. Previous other therapy to a target lesion within 30 days

8. Previous radiation therapy to a target lesion

9. Subjects having participated in any investigational drug study within 30 days prior
the study inclusion or currently participating in another clinical trial involving an
Investigational Medicinal Product (IMP).

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

correlation between % change of DCE-MRI perfusion parameters

Outcome Description:

To evaluate the correlation between % change of DCE-MRI perfusion parameters (Ktrans, AUC, kep, ve,Etc.) from baseline to follow up image at 1 & 2 weeks and the response to Sorafenib assessed by mRECIST at 2 months after initiation of treatment

Outcome Time Frame:

3 months

Safety Issue:

No

Principal Investigator

Jeong Min Lee, Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Seoul National University Hospital

Authority:

Korea: Institutional Review Board

Study ID:

DGD-44-057

NCT ID:

NCT01806740

Start Date:

March 2013

Completion Date:

August 2015

Related Keywords:

  • Hepatocellular Carcinoma
  • DCE-MRI
  • Sorafenib response
  • Carcinoma
  • Carcinoma, Hepatocellular

Name

Location