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

NCT01806740 | Terminated Phase 4 Results

• 1 other identifier: DGD-44-057
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

DCE-MRI; Sorafenib response

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Correlation Coefficient Between DCE-MRI Perfusion Parameters at Baseline and Overall Survival

  1 year

• Correlation Coefficient Between DCE-MRI Perfusion Parameters at Baseline and Progression Free Survival

  1 year

• Correlation Coefficient Between DCE-MRI Perfusion Parameters at Baseline and Time to Progression

  1 year

Study Arms (1)

Gadoterate meglumine

EXPERIMENTAL

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

Drug: Gadoterate meglumine

Interventions

Gadoterate meglumine DRUG

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.

Also known as: gadoteric acid, Dotarem

Gadoterate meglumine

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Guerbet: lead

Study Sites (1)

Guerbet Korea

Seoul, Gangnam Gu, 135-920, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

gadoterate meglumine

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Limitations and Caveats

The small number of patients included and analyzed was a major limitation to interpret the efficacy results, inducing high variability in DCE-MRI perfusion parameters, OS, PFS and TTP values.

Results Point of Contact

• Title: Corinne Dubourdieu, Head of Clinical Projects
• Organization: Guerbet

corinne.dubourdieu@guerbet.com

+33145915000

Study Officials

• Jeong Min Lee, Ph.D

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2012
• First Posted: March 7, 2013
• Study Start: May 9, 2013
• Primary Completion: October 12, 2015
• Study Completion: October 12, 2015
• Last Updated: August 8, 2019
• Results First Posted: August 8, 2019

Record last verified: 2019-06

Locations

KR (1)