Trial Outcomes & Findings for Gadoxetic Acid-MRI Versus Ultrasonography for the Surveillance of Hepatocellular Carcinoma in High-risk Patients (NCT NCT01446666)

NCT ID: NCT01446666

Last Updated: 2019-02-01

Results Overview

\- The number of patients with definite HCC detected by a given modality divided by the total number of patients with definite HCC detected by any of 2 modalities plus interval cancers

• Recruitment status: COMPLETED
• Target enrollment: 423 participants
• Primary outcome timeframe: during the 1.5-year study period (from the date of first screening to 6 months following the last screening)
• Results posted on: 2019-02-01

Participant Flow

Study participants were recruited between November 2011 and August 2012. The inclusion criteria for participation were an age of 20 years or older and the presence of cirrhosis with an estimated annual HCC risk of >5%.

The absence of hepatocellular carcinoma (HCC) had been evaluated by US, dynamic CT scan, or MRI within 6 months before enrollment. Patients with Child-Pugh class C liver function or estimated glomerular filtration rate <30 mL/min/1.73m^2 were excluded.

Participant milestones

Measure	US+MRI The patients were evaluated by three rounds of screening tests with paired US and gadoxetic acid-enhanced MRI at 6-month intervals
Overall Study STARTED	407
Overall Study COMPLETED	326
Overall Study NOT COMPLETED	81

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Gadoxetic Acid-MRI Versus Ultrasonography for the Surveillance of Hepatocellular Carcinoma in High-risk Patients

Baseline characteristics by cohort

Measure	US+MRI n=407 Participants The patients were evaluated by three rounds of screening tests with paired US and gadoxetic acid-enhanced MRI at 6-month intervals.
Age, Continuous	56 years n=5 Participants
Sex: Female, Male Female	177 Participants n=5 Participants
Sex: Female, Male Male	230 Participants n=5 Participants
Race/Ethnicity, Customized Korean	407 Participants n=5 Participants
Region of Enrollment South Korea	407 Participants n=5 Participants

PRIMARY outcome

Timeframe: during the 1.5-year study period (from the date of first screening to 6 months following the last screening)

• The number of patients with definite HCC detected by a given modality divided by the total number of patients with definite HCC detected by any of 2 modalities plus interval cancers

Outcome measures

Measure	Ultasonography n=43 Participants Results from ultrasonography	Gadoxetic Acid-enhanced MRI n=43 Participants Results from Gadoxetic acid-enhanced MRI
Detection Rate of Patients With HCC	27.9 percentage of HCC detected on each exam	86.0 percentage of HCC detected on each exam

SECONDARY outcome

Timeframe: during the 1.5-year study period (from the date of first screening to 6 months following the last screening)

• The number of patients with early stage HCC detected by a given modality divided by the total number of patients with early stage HCC detected by any of 2 modalities plus interval cancers.
• Early stage (stage A or 0) HCC is defined by the Barcelona Clinic Liver Cancer staging system (BCLC): A single HCC <5 cm or <=3 lesions each <3 cm in diameter, without gross vascular invasion or extrahepatic metastasis.

Outcome measures

Measure	Ultasonography n=42 Participants Results from ultrasonography	Gadoxetic Acid-enhanced MRI n=42 Participants Results from Gadoxetic acid-enhanced MRI
Detection Rate of Patients With Early Stage HCC	26.2 percentage of early HCC detected	85.7 percentage of early HCC detected

SECONDARY outcome

Timeframe: during the 1.5-year study period (from the date of first screening to 6 months following the last screening)

Population: Of the 43 patients, 32 (74.4%) had very early-stage.

• The number of patients with HCC nodules of very early stage detected by a given modality divided by the total number of definite HCC nodules of very early stage detected by any of 2 modalities plus interval cancers.
• Very early stage (stage 0) HCC is defined by the Barcelona Clinic Liver Cancer staging system (BCLC): A single HCC <2 cm without gross vascular invasion or extrahepatic metastasis.

Outcome measures

Measure	Ultasonography n=32 Participants Results from ultrasonography	Gadoxetic Acid-enhanced MRI n=32 Participants Results from Gadoxetic acid-enhanced MRI
Detection Rate of Patients With Very Early Stage HCC	27.3 percentage of detected very early HCC	84.8 percentage of detected very early HCC

SECONDARY outcome

Timeframe: during the 1.5-year study period (from the date of first screening to 6 months following the last screening)

The false-positive rate was defined as the number of tests with positive findings by a specific imaging modality in patients without a HCC.

Outcome measures

Measure	Ultasonography n=1057 the number of exams Results from ultrasonography	Gadoxetic Acid-enhanced MRI n=1057 the number of exams Results from Gadoxetic acid-enhanced MRI
False Positive Rate	5.6 percentage of false positive test	3.0 percentage of false positive test

SECONDARY outcome

Timeframe: during the 1.5-year study period (from the date of first screening to 6 months following the last screening)

The positive predictive value was the number of true positive test results in patients with the positive tests in a specific modality.

Outcome measures

Measure	Ultasonography n=71 Participants Results from ultrasonography	Gadoxetic Acid-enhanced MRI n=69 Participants Results from Gadoxetic acid-enhanced MRI
Positive Predictive Value for HCC	16.9 percentage of true positive calls	53.6 percentage of true positive calls

Adverse Events

US+MRI

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Professor Young-Suk Lim

Asan Medical Center, University of Ulsan College of Medicine

Phone: +82-02-3010-5933

Email: limys@amc.seoul.kr

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place