Trial Outcomes & Findings for Detection of Liver Fibrosis With Magnetic Resonance Imaging (MRI) (NCT NCT01600105)

Results Overview

Sub-Study I Portal Venous Flow - forward flow during systole and early diastole, and flow reversal after atrial contraction.The average PV area was extracted, and PV flow was computed as the multiplication of area and velocity.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

276 participants

Primary outcome timeframe

Fasting State Scan (an average of 15 min) and Postprandial State Scan (an average of 15 min)

Results posted on

2020-02-07

Participant Flow

Recruitment began in May 2010, with enrollment from October 2010 through February 2017. Patients were recruited from the Division of Liver Diseases or from the Surgical Oncology Clinic at Mount Sinai.

Participant milestones

Participant milestones
Measure	Chronic Liver Disease Patients chronic liver disease who underwent/will undergo liver biopsy or will undergo liver transplant or liver resection as part of standard care during the previous 6 months. Sub Study I: Patients were enrolled in the study if they had a liver biopsy performed within 3 months of the MRI study or were diagnosed with liver cirrhosis based on imaging findings. Sub Study II: Patients with mixed etiology of liver fibrosis proven by biopsy, and/or liver cirrhosis. Sub study III: Patients with chronic liver disease who underwent invasive hepatic vein pressure gradient (HVPG) measurement	Healthy Volunteers Healthy Volunteer for Sub study I
Total Participants STARTED	255	21
Total Participants COMPLETED	214	11
Total Participants NOT COMPLETED	41	10
Sub Study I STARTED	19	21
Sub Study I COMPLETED	19	11
Sub Study I NOT COMPLETED	0	10
Sub Study II STARTED	65	0
Sub Study II COMPLETED	60	0
Sub Study II NOT COMPLETED	5	0
Sub Study III STARTED	39	0
Sub Study III COMPLETED	34	0
Sub Study III NOT COMPLETED	5	0
Sub Study IV STARTED	41	8
Sub Study IV COMPLETED	41	8
Sub Study IV NOT COMPLETED	0	0
Sub Study V STARTED	52	0
Sub Study V COMPLETED	50	0
Sub Study V NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Chronic Liver Disease Patients chronic liver disease who underwent/will undergo liver biopsy or will undergo liver transplant or liver resection as part of standard care during the previous 6 months. Sub Study I: Patients were enrolled in the study if they had a liver biopsy performed within 3 months of the MRI study or were diagnosed with liver cirrhosis based on imaging findings. Sub Study II: Patients with mixed etiology of liver fibrosis proven by biopsy, and/or liver cirrhosis. Sub study III: Patients with chronic liver disease who underwent invasive hepatic vein pressure gradient (HVPG) measurement	Healthy Volunteers Healthy Volunteer for Sub study I
Total Participants Withdrawal by Subject	1	0
Total Participants No images in PACS	10	0
Total Participants Insufficient image quality	30	10
Sub Study I Insufficient image quality	0	10
Sub Study II Withdrawal by Subject	1	0
Sub Study II No images in PACS	1	0
Sub Study II Insufficient image quality	3	0
Sub Study III Insufficient image quality	5	0
Sub Study V Poor Image Quality	2	0

Baseline Characteristics

Sub-study II with 60 participants

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Fasting State Scan (an average of 15 min) and Postprandial State Scan (an average of 15 min)

Sub-Study I Portal Venous Flow - forward flow during systole and early diastole, and flow reversal after atrial contraction.The average PV area was extracted, and PV flow was computed as the multiplication of area and velocity.

Outcome measures

Outcome measures
Measure	Chronic Hep C Patients n=19 Participants chronic liver disease who underwent/will undergo liver biopsy or will undergo liver transplant or liver resection as part of standard care during the previous 6 months. Perfusion MRI: 1) Assess the role of a new FDA approved blood pool gadolinium contrast agent (gadofosveset trisodium, Ablavar, Lantheus) for the measurement of liver MR Perfusion, compared to extra-cellular contrast agents.	Healthy Volunteers n=11 Participants No Hep C
PV Flow Fasting	16.0 ml/s Standard Deviation 6.1	15.5 ml/s Standard Deviation 4.2
PV Flow Postprandial	23.2 ml/s Standard Deviation 8.5	27.1 ml/s Standard Deviation 10.2

PRIMARY outcome

Timeframe: Fasting State Scan (an average of 15 min) and Postprandial State Scan (an average of 15 min)

Sub-Study I Portal Venous Flow Velocity - The mean velocity of the region of interest (ROI) was extracted for each one of the 25 phase images, and the time average was computed.

Outcome measures

Outcome measures
Measure	Chronic Hep C Patients n=19 Participants chronic liver disease who underwent/will undergo liver biopsy or will undergo liver transplant or liver resection as part of standard care during the previous 6 months. Perfusion MRI: 1) Assess the role of a new FDA approved blood pool gadolinium contrast agent (gadofosveset trisodium, Ablavar, Lantheus) for the measurement of liver MR Perfusion, compared to extra-cellular contrast agents.	Healthy Volunteers n=11 Participants No Hep C
PV Velocity Fasting	10.5 cm/s Standard Deviation 3.2	11.5 cm/s Standard Deviation 2.8
PV Velocity Postprandial	12.8 cm/s Standard Deviation 4.6	14.4 cm/s Standard Deviation 3.2

PRIMARY outcome

Timeframe: Fasting State Scan (an average of 15 min) and Postprandial State Scan (an average of 15 min)

Population: Sub Study I with 30 participants. The method failed in 3 of the patients, so no usable LS-MRE data was generated. 27 patients had usable data for PV flow and velocity, so they were included in the study.

Sub-Study I Liver stiffness (LS) measured by magnetic resonance elastography (MRE) in kilopascal (kPa). Liver stiffness is assessed by mathematical modeling of compression waves propagation in the liver, as measured from MRE images.

Outcome measures

Outcome measures
Measure	Chronic Hep C Patients n=19 Participants chronic liver disease who underwent/will undergo liver biopsy or will undergo liver transplant or liver resection as part of standard care during the previous 6 months. Perfusion MRI: 1) Assess the role of a new FDA approved blood pool gadolinium contrast agent (gadofosveset trisodium, Ablavar, Lantheus) for the measurement of liver MR Perfusion, compared to extra-cellular contrast agents.	Healthy Volunteers n=11 Participants No Hep C
LS-MRE for Sub-Study I Fasting	4.9 kPa Standard Deviation 1.4	1.8 kPa Standard Deviation 0.2
LS-MRE for Sub-Study I Postprandial	5.0 kPa Standard Deviation 1.2	2.0 kPa Standard Deviation 0.2

PRIMARY outcome

Timeframe: Fasting State Multiparametric MRI Scan (an average of 60 min) Scan

Population: 3 participants with scans not evaluable

Sub-Study II True Diffusion Parameter - D- describes water diffusion in tissue independently from the effects of capillary perfusion; it is obtained from bi-exponential fitting of MRI diffusion signal acquired over a range of high and low diffusion-weighting factors (b-values) Fibrosis State/Score: F0-F2 - no signs of fibrosis to minimal fibrosis F3-F4 - fibrosis has spread and has connected to other areas on the liver that contain fibrosis or presence of cirrhosis

Outcome measures

Outcome measures
Measure	Chronic Hep C Patients n=57 Participants chronic liver disease who underwent/will undergo liver biopsy or will undergo liver transplant or liver resection as part of standard care during the previous 6 months. Perfusion MRI: 1) Assess the role of a new FDA approved blood pool gadolinium contrast agent (gadofosveset trisodium, Ablavar, Lantheus) for the measurement of liver MR Perfusion, compared to extra-cellular contrast agents.	Healthy Volunteers No Hep C
True Diffusion Parameter (D) F0-F2	1.06 10^-3 mm^2/s Standard Deviation 0.21	—
True Diffusion Parameter (D) F3-F4	0.94 10^-3 mm^2/s Standard Deviation 0.16	—

PRIMARY outcome

Timeframe: Fasting State Multiparametric MRI Scan (an average of 60 min)

Population: Only 38 participants had suitable MRE quality for analysis.

Sub-Study II Liver stiffness (LS) measured by magnetic resonance elastography (MRE) in kilopascal (kPa). Liver stiffness is assessed by mathematical modeling of compression waves propagation in the liver, as measured from MRE images. Fibrosis State/Score: F0-F2 - no signs of fibrosis to minimal fibrosis F3-F4 - fibrosis has spread and has connected to other areas on the liver that contain fibrosis or presence of cirrhosis

Outcome measures

Outcome measures
Measure	Chronic Hep C Patients n=38 Participants chronic liver disease who underwent/will undergo liver biopsy or will undergo liver transplant or liver resection as part of standard care during the previous 6 months. Perfusion MRI: 1) Assess the role of a new FDA approved blood pool gadolinium contrast agent (gadofosveset trisodium, Ablavar, Lantheus) for the measurement of liver MR Perfusion, compared to extra-cellular contrast agents.	Healthy Volunteers No Hep C
LS-MRE Fibrosis State for Sub Study II F0-F2	2.88 kPa Standard Deviation 0.91	—
LS-MRE Fibrosis State for Sub Study II F3-F4	5.16 kPa Standard Deviation 0.95	—

PRIMARY outcome

Timeframe: Fasting transient elastography, average duration 10 min

Population: Only 46 participants had suitable TE quality for analysis.

Sub-Study II Liver Stiffness with transient elastography (TE) (LS-TE) - a non-invasive modality of liver fibrosis detection: a shear wave is sent into the liver through a small transducer attached to an ultrasound probe, and the velocity of the wave is measured as it passes through the liver; shear wave velocity is then converted to stiffness, measured in kilopascals (kPa) Fibrosis State/Score: F0-F2 - no signs of fibrosis to minimal fibrosis F3-F4 - fibrosis has spread and has connected to other areas on the liver that contain fibrosis or presence of cirrhosis

Outcome measures

Outcome measures
Measure	Chronic Hep C Patients n=46 Participants chronic liver disease who underwent/will undergo liver biopsy or will undergo liver transplant or liver resection as part of standard care during the previous 6 months. Perfusion MRI: 1) Assess the role of a new FDA approved blood pool gadolinium contrast agent (gadofosveset trisodium, Ablavar, Lantheus) for the measurement of liver MR Perfusion, compared to extra-cellular contrast agents.	Healthy Volunteers No Hep C
LS-TE F0-F2	9.55 kPa Standard Deviation 6.85	—
LS-TE F3-F4	21.44 kPa Standard Deviation 17.86	—

PRIMARY outcome

Timeframe: Fasting State Multiparametric MRI Scan (an average of 60 min)

Population: Only 50 participants had suitable quality MRI for analysis

Sub-Study II Mean Transit Time (MTT) - Liver Mean Transit Time of Contrast Agent through the tissue of interest from Dynamic Contrast Enhanced MRI Fibrosis State/Score: F0-F2 - no signs of fibrosis to minimal fibrosis F3-F4 - fibrosis has spread and has connected to other areas on the liver that contain fibrosis or presence of cirrhosis

Outcome measures

Outcome measures
Measure	Chronic Hep C Patients n=50 Participants chronic liver disease who underwent/will undergo liver biopsy or will undergo liver transplant or liver resection as part of standard care during the previous 6 months. Perfusion MRI: 1) Assess the role of a new FDA approved blood pool gadolinium contrast agent (gadofosveset trisodium, Ablavar, Lantheus) for the measurement of liver MR Perfusion, compared to extra-cellular contrast agents.	Healthy Volunteers No Hep C
MTT F0-F2	11.6 seconds Standard Deviation 8.1	—
MTT F3-F4	18.8 seconds Standard Deviation 9.1	—

SECONDARY outcome

Timeframe: Fasting State Multiparametric MRI Scan (an average of 60 min)

Population: Among the 34 patients, 2 patients did not have DCE-MRI acquisition due to chronic renal insufficiency, 4 patients had non-usable DCE-MRI data because of major artifacts.

Sub-Study III Liver Upslope of MRI signal is defined as peak concentration to the time to reach peak concentration of gadolinium contrast agent in the liver tissue of interest, derived from dynamic contrast-enhanced MRI (DCE-MRI. Portal hypertension (PH), defined by hepatic venous pressure gradient (HVPG) ≥5 mmHg Clinically Significant Portal hypertension (CSPH), defined by hepatic venous pressure gradient (HVPG) ≥10 mmHg

Outcome measures

Outcome measures
Measure	Chronic Hep C Patients n=28 Participants chronic liver disease who underwent/will undergo liver biopsy or will undergo liver transplant or liver resection as part of standard care during the previous 6 months. Perfusion MRI: 1) Assess the role of a new FDA approved blood pool gadolinium contrast agent (gadofosveset trisodium, Ablavar, Lantheus) for the measurement of liver MR Perfusion, compared to extra-cellular contrast agents.	Healthy Volunteers No Hep C
Liver Upslope From DCE-MRI HVPG <5mmHg	0.011 mmol/(L.s)) Standard Deviation 0.011	—
Liver Upslope From DCE-MRI HVPG>=5mmHg	0.0007 mmol/(L.s)) Standard Deviation 0.0007	—
Liver Upslope From DCE-MRI HPVG<10mmHg	0.011 mmol/(L.s)) Standard Deviation 0.007	—
Liver Upslope From DCE-MRI HPVG>=10mmHg	0.0006 mmol/(L.s)) Standard Deviation 0.004	—

SECONDARY outcome

Timeframe: Fasting State Multiparametric MRI Scan (an average of 60 min)

Population: Among the 34 patients, 2 patients did not have DCE-MRI acquisition due to chronic renal insufficiency, 4 patients had non-usable DCE-MRI data because of major artifacts..

Sub-Study III Liver Time to Peak (TTP) is defined as the time in seconds to reach peak concentration of gadolinium contrast agent in the liver tissue of interest, derived from dynamic contrast-enhanced MRI (DCE-MRI) Portal hypertension (PH), defined by hepatic venous pressure gradient (HVPG) ≥5 mmHg Clinically Significant Portal Hypertension is defined as an HVPG ≥10 mmHg

Outcome measures

Outcome measures
Measure	Chronic Hep C Patients n=28 Participants chronic liver disease who underwent/will undergo liver biopsy or will undergo liver transplant or liver resection as part of standard care during the previous 6 months. Perfusion MRI: 1) Assess the role of a new FDA approved blood pool gadolinium contrast agent (gadofosveset trisodium, Ablavar, Lantheus) for the measurement of liver MR Perfusion, compared to extra-cellular contrast agents.	Healthy Volunteers No Hep C
Liver Time to Peak (TTP) for PH HVPG<10mmHg	41.47 seconds Standard Deviation 25.76	—
Liver Time to Peak (TTP) for PH HVPG>=10mmHg	69.45 seconds Standard Deviation 41.98	—
Liver Time to Peak (TTP) for PH HVPG<5mmHg	40.99 seconds Standard Deviation 22.20	—
Liver Time to Peak (TTP) for PH HVPG>=5mmHg	53.02 seconds Standard Deviation 31.8	—

SECONDARY outcome

Timeframe: Fasting State Multiparametric MRI Scan (an average of 60 min)

Population: MRE was successful for liver stiffness measurements in 31 participants of the 34

Sub-Study III Liver stiffness (LS) measured by magnetic resonance elastography (MRE) in kilopascal (kPa). Liver stiffness is assessed by mathematical modeling of compression waves propagation in the liver, as measured from MRE images. Portal Hypertension is defined as an HVPG ≥5 mmHg Clinically Significant Portal hypertension (CSPH), defined by hepatic venous pressure gradient (HVPG) ≥10 mmHg

Outcome measures

Outcome measures
Measure	Chronic Hep C Patients n=31 Participants chronic liver disease who underwent/will undergo liver biopsy or will undergo liver transplant or liver resection as part of standard care during the previous 6 months. Perfusion MRI: 1) Assess the role of a new FDA approved blood pool gadolinium contrast agent (gadofosveset trisodium, Ablavar, Lantheus) for the measurement of liver MR Perfusion, compared to extra-cellular contrast agents.	Healthy Volunteers No Hep C
LS-MRE Portal Hypertension for Sub Study III HVPG<5mmHg	2.31 kPa Standard Deviation 2.8	—
LS-MRE Portal Hypertension for Sub Study III HVPG>=5mmHg	5.14 kPa Standard Deviation 2.57	—
LS-MRE Portal Hypertension for Sub Study III HVPG<10mmHg	3.88 kPa Standard Deviation 3.16	—
LS-MRE Portal Hypertension for Sub Study III HVPG>=10mmHg	5.86 kPa Standard Deviation 6.71	—

SECONDARY outcome

Timeframe: Fasting State Multiparametric MRI Scan (an average of 60 min)

Population: Sub Study III with 34 participants

Sub-Study III Portal Hypertension is defined as an HVPG ≥5 mmHg

Outcome measures

Outcome measures
Measure	Chronic Hep C Patients n=34 Participants chronic liver disease who underwent/will undergo liver biopsy or will undergo liver transplant or liver resection as part of standard care during the previous 6 months. Perfusion MRI: 1) Assess the role of a new FDA approved blood pool gadolinium contrast agent (gadofosveset trisodium, Ablavar, Lantheus) for the measurement of liver MR Perfusion, compared to extra-cellular contrast agents.	Healthy Volunteers No Hep C
Spleen Volume HVPG<5mmHg	246 cm^3 Standard Deviation 252	—
Spleen Volume HVPG>=5mmHg	441 cm^3 Standard Deviation 629	—

SECONDARY outcome

Timeframe: Fasting State Multiparametric MRI Scan (an average of 60 min)

Population: Sub Study III with 34 participants

Sub-Study III Portal Hypertension is defined as an HVPG ≥5 mmHg

Outcome measures

Outcome measures
Measure	Chronic Hep C Patients n=34 Participants chronic liver disease who underwent/will undergo liver biopsy or will undergo liver transplant or liver resection as part of standard care during the previous 6 months. Perfusion MRI: 1) Assess the role of a new FDA approved blood pool gadolinium contrast agent (gadofosveset trisodium, Ablavar, Lantheus) for the measurement of liver MR Perfusion, compared to extra-cellular contrast agents.	Healthy Volunteers No Hep C
Spleen Caudocranial Diameter HVPG<5mmHg	11.6 cm Standard Deviation 2.8	—
Spleen Caudocranial Diameter HVPG>=5mmHg	14.0 cm Standard Deviation 4.8	—

SECONDARY outcome

Timeframe: Fasting State Multiparametric MRI Scan (an average of 60 min)

Population: Sub Study III with 34 participants

Sub-Study III Portal Hypertension imaging composite score (based on the presence of varices, spleen size, presence of ascites). The imaging score is based on the number of variceal sites (0: absence of varices, 1: one variceal site, 2: two variceal sites, and 3: 3 or more variceal sites), volume of ascites (0: no ascites, 1: minimal perihepatic and perisplenic fluid, 2: intraperitoneal fluid without marked abdominal wall distension, and 3: fluid causing marked abdominal wall distension), and maximum craniocaudal diameter of the spleen (0: size less than 13 cm, 1: size between 13 and 15 cm, 2: size between 15 and 20 cm, and 3: size greater than 20 cm). Score from 0 to 9, with higher score indicating worse disease. Portal Hypertension is defined as an HVPG ≥5 mmHg Clinically Significant Portal hypertension (CSPH), defined by hepatic venous pressure gradient (HVPG) ≥10 mmHg

Outcome measures

Outcome measures
Measure	Chronic Hep C Patients n=34 Participants chronic liver disease who underwent/will undergo liver biopsy or will undergo liver transplant or liver resection as part of standard care during the previous 6 months. Perfusion MRI: 1) Assess the role of a new FDA approved blood pool gadolinium contrast agent (gadofosveset trisodium, Ablavar, Lantheus) for the measurement of liver MR Perfusion, compared to extra-cellular contrast agents.	Healthy Volunteers No Hep C
PH Imaging Score HVPG>=5mmHg	2 score on a scale Standard Deviation 5.25	—
PH Imaging Score HVPG<10	1 score on a scale Standard Deviation 1.5	—
PH Imaging Score HVPG>=10	4 score on a scale Standard Deviation 4.5	—
PH Imaging Score HVPG<5mmHg	0 score on a scale Standard Deviation 1	—

SECONDARY outcome

Timeframe: Fasting State Multiparametric MRI Scan (an average of 60 min)

Population: 31 of the 34 participants had LS-MRE and 28 of the 34 participants had Liver Upslope measurement from DCE-MRI

Sub-Study III Liver Stiffness to Liver Upslope ratio (LSLU) Portal Hypertension is defined as an HVPG ≥5 mmHg Clinically Significant Portal hypertension (CSPH), defined by hepatic venous pressure gradient (HVPG) ≥10 mmHg

Outcome measures

Outcome measures
Measure	Chronic Hep C Patients n=28 Participants chronic liver disease who underwent/will undergo liver biopsy or will undergo liver transplant or liver resection as part of standard care during the previous 6 months. Perfusion MRI: 1) Assess the role of a new FDA approved blood pool gadolinium contrast agent (gadofosveset trisodium, Ablavar, Lantheus) for the measurement of liver MR Perfusion, compared to extra-cellular contrast agents.	Healthy Volunteers No Hep C
LSLU HVPG<5mmHg	192.72 kPasL/mmol Standard Deviation 195.65	—
LSLU HVPG>=5mmHg	830.28 kPasL/mmol Standard Deviation 971.68	—
LSLU HVPG<10mmHg	363.68 kPasL/mmol Standard Deviation 855.01	—
LSLU HVPG>10mmHg	871.82 kPasL/mmol Standard Deviation 1354.31	—

SECONDARY outcome

Timeframe: Fasting State Multiparametric MRI Scan (an average of 60 min)

Population: Among the 34 patients, 2 patients did not have DCE-MRI acquisition due to chronic renal insufficiency, 4 patients had non-usable DCE-MRI data because of major artifacts.

Sub Study III Liver Distribution Volume (DV) is the distribution volume of contrast agent in the tissue of interest defined as a percentage ratio of gadolinium material volume to the volume of the liver tissue of interest, as derived from DCE-MRI; in the case of a contrast agent with extracellular distribution, DV measures the intravascular and extravascular-extracellular volume. Clinically Significant Portal hypertension (CSPH), defined by hepatic venous pressure gradient (HVPG) ≥10 mmHg

Outcome measures

Outcome measures
Measure	Chronic Hep C Patients n=28 Participants chronic liver disease who underwent/will undergo liver biopsy or will undergo liver transplant or liver resection as part of standard care during the previous 6 months. Perfusion MRI: 1) Assess the role of a new FDA approved blood pool gadolinium contrast agent (gadofosveset trisodium, Ablavar, Lantheus) for the measurement of liver MR Perfusion, compared to extra-cellular contrast agents.	Healthy Volunteers No Hep C
Liver DV HVPG<10mmHg	47.28 percentage of liver volume Standard Deviation 24.29	—
Liver DV HVPG>=10mmHg	77.25 percentage of liver volume Standard Deviation 111.01	—

SECONDARY outcome

Timeframe: Fasting State Multiparametric MRI Scan (an average of 60 min)

Population: Among the 34 patients, 2 patients did not have DCE-MRI acquisition due to chronic renal insufficiency, 4 patients had non-usable DCE-MRI data because of major artifacts.

Sub Study III Spleen Time To Peak (TTP) - time to reach peak gadolinium concentration in spleen tissue of interest, derived from DCE-MRI. Clinically Significant Portal hypertension (CSPH), defined by hepatic venous pressure gradient (HVPG) ≥10 mmHg

Outcome measures

Outcome measures
Measure	Chronic Hep C Patients n=28 Participants chronic liver disease who underwent/will undergo liver biopsy or will undergo liver transplant or liver resection as part of standard care during the previous 6 months. Perfusion MRI: 1) Assess the role of a new FDA approved blood pool gadolinium contrast agent (gadofosveset trisodium, Ablavar, Lantheus) for the measurement of liver MR Perfusion, compared to extra-cellular contrast agents.	Healthy Volunteers No Hep C
Spleen TTP HVPG<10mmHg	15.46 seconds Standard Deviation 16.65	—
Spleen TTP HVPG>=10mmHg	44.90 seconds Standard Deviation 40.69	—

Adverse Events

Sub Study 1 Chronic Hep C Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sub Study 1 Health Volunteers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sub Study II

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Sub Study III

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Total Participants of the Substudies

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Sub Study 1 Chronic Hep C Patients n=19 participants at risk Quantitative Liver MRI Combining Phase Contrast Imaging, Elastography, and DWI: Assessment of Reproducibility and Postprandial Effect Description: Patients with liver disease who had portal vein (PV) flow parameters measured with phase contrast (PC) imaging, liver diffusion parameters measured with multiple b value diffusion-weighted imaging (DWI) and liver stiffness (LS) measured with MR elastography (MRE) in fasting conditions and after a meal challenge.	Sub Study 1 Health Volunteers n=11 participants at risk Quantitative Liver MRI Combining Phase Contrast Imaging, Elastography, and DWI: Assessment of Reproducibility and Postprandial Effect Description: Healthy volunteers who had portal vein (PV) flow parameters measured with phase contrast (PC) imaging, liver diffusion parameters measured with multiple b value diffusion-weighted imaging (DWI) and liver stiffness (LS) measured with MR elastography (MRE) in fasting conditions and after a meal challenge.	Sub Study II n=60 participants at risk Arm/Group Title: Prospective Comparison of Magnetic Resonance Imaging to Transient Elastography and Serum Markers for Liver Fibrosis Detection Description: Chronic liver disease patients who underwent a multiparametric magnetic resonance imaging (MRI) protocol including diffusion�\\weighted imaging (DWI), dynamic contrast�\\enhanced (DCE)�\\MRI and magnetic resonance elastography (MRE) in comparison with transient elastography (TE) for liver fibrosis detection.	Sub Study III n=34 participants at risk Noninvasive Prediction of Portal Pressure with MR Elastography and DCE�\\MRI of the Liver and Spleen Description: Chronic liver disease patients who underwent HVPG measurement, MR elastography (MRE) and dynamic contrast�\\enhanced MRI (DCE�\\MRI) of the liver and spleen	Total Participants of the Substudies n=124 participants at risk Total participants of Sub Study 1, Sub Study II, and Sub Study III
Skin and subcutaneous tissue disorders Rash	0.00% 0/19 • 6 years	0.00% 0/11 • 6 years	1.7% 1/60 • 6 years	0.00% 0/34 • 6 years	0.81% 1/124 • 6 years
Nervous system disorders Fainting	0.00% 0/19 • 6 years	0.00% 0/11 • 6 years	1.7% 1/60 • 6 years	0.00% 0/34 • 6 years	0.81% 1/124 • 6 years

Additional Information

Dr. Bachir Taouli

Icahn School of Medicine at Mount Sinai

Phone: 212-824-8475

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Perfusion MRI n=214 Participants chronic liver disease who underwent/will undergo liver biopsy or will undergo liver transplant or liver resection as part of standard care during the previous 6 months. Perfusion MRI: 1) Assess the role of a new FDA approved blood pool gadolinium contrast agent (gadofosveset trisodium, Ablavar, Lantheus) for the measurement of liver MR Perfusion, compared to extra-cellular contrast agents.	Healthy Volunteers n=11 Participants Healthy Volunteers in Sub study I only	Total n=225 Participants Total of all reporting groups
Sex: Female, Male Female	20 Participants n=52 Participants • Sub Study V had 52 participants	5 Participants n=8 Participants • Sub Study IV had 49 participants	20 Participants n=52 Participants • Sub Study V had 52 participants
Age, Continuous	53.8 years n=214 Participants	30.6 years n=11 Participants	51.8 years n=225 Participants
Age, Customized Sub Study I Chronic Hepatitis C patients	55.8 years n=19 Participants • 30 Participants in Sub Study I: 11 healthy volunteers and 19 patients	30.6 years n=11 Participants • 30 Participants in Sub Study I: 11 healthy volunteers and 19 patients	46.5 years n=30 Participants • 30 Participants in Sub Study I: 11 healthy volunteers and 19 patients
Age, Customized Sub Study II	55 years n=60 Participants • Sub-Study II with 60 participants	—	55 years n=60 Participants • Sub-Study II with 60 participants
Age, Customized Sub Study III	53 years n=34 Participants • Sub-Study III 34 participants who underwent HVPG measurements	—	53 years n=34 Participants • Sub-Study III 34 participants who underwent HVPG measurements
Age, Customized Sub Study IV	53 years n=41 Participants • Sub Study IV had 49 participants - 41 with chronic liver disease and 8 healthy volunteers	29 years n=8 Participants • Sub Study IV had 49 participants - 41 with chronic liver disease and 8 healthy volunteers	48 years n=49 Participants • Sub Study IV had 49 participants - 41 with chronic liver disease and 8 healthy volunteers
Age, Customized Sub Study V	57 years n=52 Participants • Sub Study V had 52 participants	—	57 years n=52 Participants • Sub Study V had 52 participants
Sex: Female, Male Male	32 Participants n=52 Participants • Sub Study V had 52 participants	3 Participants n=8 Participants • Sub Study IV had 49 participants	32 Participants n=52 Participants • Sub Study V had 52 participants
Sex: Female, Male Chronic Hepatitis C patients · Female	2 Participants n=19 Participants • 30 Participants in Sub Study I	5 Participants n=11 Participants • 30 Participants in Sub Study I	7 Participants n=30 Participants • 30 Participants in Sub Study I
Sex: Female, Male Chronic Hepatitis C patients · Male	17 Participants n=19 Participants • 30 Participants in Sub Study I	6 Participants n=11 Participants • 30 Participants in Sub Study I	23 Participants n=30 Participants • 30 Participants in Sub Study I
Race/Ethnicity, Customized White	105 Participants n=214 Participants • Participants who completed study.	3 Participants n=11 Participants • Participants who completed study.	108 Participants n=225 Participants • Participants who completed study.
Race/Ethnicity, Customized Asian	31 Participants n=214 Participants • Participants who completed study.	1 Participants n=11 Participants • Participants who completed study.	32 Participants n=225 Participants • Participants who completed study.
Race/Ethnicity, Customized Black or African American	20 Participants n=214 Participants • Participants who completed study.	5 Participants n=11 Participants • Participants who completed study.	25 Participants n=225 Participants • Participants who completed study.
Race/Ethnicity, Customized Hispanic	38 Participants n=214 Participants • Participants who completed study.	2 Participants n=11 Participants • Participants who completed study.	40 Participants n=225 Participants • Participants who completed study.
Race/Ethnicity, Customized Unknown	20 Participants n=214 Participants • Participants who completed study.	0 Participants n=11 Participants • Participants who completed study.	20 Participants n=225 Participants • Participants who completed study.