Trial Outcomes & Findings for Evaluation of Liver Cancer With Magnetic Resonance Imaging (MRI) (NCT NCT01871545)
NCT ID: NCT01871545
Last Updated: 2020-07-09
Results Overview
Tumor diffusion (apparent diffusion coefficient) measured with diffusion-weighted imaging sequence
COMPLETED
NA
84 participants
Day 1
2020-07-09
Participant Flow
Enrollment from June 2013 through February 2018
Participant milestones
| Measure |
Hepatocellular Carcinoma (HCC)
Participant with hepatocellular carcinoma (HCC)
|
Healthy Volunteer
Healthy volunteer participant
|
|---|---|---|
|
Overall Study
STARTED
|
73
|
11
|
|
Overall Study
COMPLETED
|
56
|
8
|
|
Overall Study
NOT COMPLETED
|
17
|
3
|
Reasons for withdrawal
| Measure |
Hepatocellular Carcinoma (HCC)
Participant with hepatocellular carcinoma (HCC)
|
Healthy Volunteer
Healthy volunteer participant
|
|---|---|---|
|
Overall Study
Death
|
2
|
0
|
|
Overall Study
Lack of Efficacy
|
11
|
2
|
|
Overall Study
Physician Decision
|
4
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Data analysis only for a subset of patients with HCC undergoing hepatic resection compared to healthy controls.
Baseline characteristics by cohort
| Measure |
Hepatocellular Carcinoma (HCC)
n=56 Participants
Participants with hepatocellular carcinoma (HCC)
|
Healthy Participant
n=8 Participants
Healthy control participants
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65 years
n=56 Participants
|
36 years
n=8 Participants
|
62 years
n=64 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=56 Participants
|
7 Participants
n=8 Participants
|
19 Participants
n=64 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=56 Participants
|
1 Participants
n=8 Participants
|
45 Participants
n=64 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=56 Participants
|
1 Participants
n=8 Participants
|
18 Participants
n=64 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=56 Participants
|
7 Participants
n=8 Participants
|
43 Participants
n=64 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=56 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=64 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=56 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=64 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=56 Participants
|
3 Participants
n=8 Participants
|
7 Participants
n=64 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=56 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=64 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=56 Participants
|
1 Participants
n=8 Participants
|
19 Participants
n=64 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=56 Participants
|
4 Participants
n=8 Participants
|
35 Participants
n=64 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=56 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=64 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=56 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=64 Participants
|
|
SubStudy 1: Age
|
59 years
n=32 Participants • Data analysis only for a subset of patients with HCC undergoing hepatic resection compared to healthy controls.
|
36 years
n=8 Participants • Data analysis only for a subset of patients with HCC undergoing hepatic resection compared to healthy controls.
|
59 years
n=40 Participants • Data analysis only for a subset of patients with HCC undergoing hepatic resection compared to healthy controls.
|
|
SubStudy 1: Sex
Female
|
6 Participants
n=32 Participants • Data analysis only for a subset of patients with HCC undergoing hepatic resection compared to healthy controls.
|
7 Participants
n=8 Participants • Data analysis only for a subset of patients with HCC undergoing hepatic resection compared to healthy controls.
|
13 Participants
n=40 Participants • Data analysis only for a subset of patients with HCC undergoing hepatic resection compared to healthy controls.
|
|
SubStudy 1: Sex
Male
|
26 Participants
n=32 Participants • Data analysis only for a subset of patients with HCC undergoing hepatic resection compared to healthy controls.
|
1 Participants
n=8 Participants • Data analysis only for a subset of patients with HCC undergoing hepatic resection compared to healthy controls.
|
27 Participants
n=40 Participants • Data analysis only for a subset of patients with HCC undergoing hepatic resection compared to healthy controls.
|
|
SubStudy 1: Ethnicity
Hispanic or Latino
|
7 Participants
n=32 Participants • Data analysis only for a subset of patients with HCC undergoing hepatic resection compared to healthy controls.
|
1 Participants
n=8 Participants • Data analysis only for a subset of patients with HCC undergoing hepatic resection compared to healthy controls.
|
8 Participants
n=40 Participants • Data analysis only for a subset of patients with HCC undergoing hepatic resection compared to healthy controls.
|
|
SubStudy 1: Ethnicity
Not Hispanic or Latino
|
24 Participants
n=32 Participants • Data analysis only for a subset of patients with HCC undergoing hepatic resection compared to healthy controls.
|
7 Participants
n=8 Participants • Data analysis only for a subset of patients with HCC undergoing hepatic resection compared to healthy controls.
|
31 Participants
n=40 Participants • Data analysis only for a subset of patients with HCC undergoing hepatic resection compared to healthy controls.
|
|
SubStudy 1: Ethnicity
Unknown or Not Reported
|
1 Participants
n=32 Participants • Data analysis only for a subset of patients with HCC undergoing hepatic resection compared to healthy controls.
|
0 Participants
n=8 Participants • Data analysis only for a subset of patients with HCC undergoing hepatic resection compared to healthy controls.
|
1 Participants
n=40 Participants • Data analysis only for a subset of patients with HCC undergoing hepatic resection compared to healthy controls.
|
|
SubStudy 1: Race
American Indian or Alaska Native
|
0 Participants
n=32 Participants • Data analysis only for a subset of patients with HCC undergoing hepatic resection compared to healthy controls.
|
0 Participants
n=8 Participants • Data analysis only for a subset of patients with HCC undergoing hepatic resection compared to healthy controls.
|
0 Participants
n=40 Participants • Data analysis only for a subset of patients with HCC undergoing hepatic resection compared to healthy controls.
|
|
SubStudy 1: Race
Asian
|
3 Participants
n=32 Participants • Data analysis only for a subset of patients with HCC undergoing hepatic resection compared to healthy controls.
|
3 Participants
n=8 Participants • Data analysis only for a subset of patients with HCC undergoing hepatic resection compared to healthy controls.
|
6 Participants
n=40 Participants • Data analysis only for a subset of patients with HCC undergoing hepatic resection compared to healthy controls.
|
|
SubStudy 1: Race
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=32 Participants • Data analysis only for a subset of patients with HCC undergoing hepatic resection compared to healthy controls.
|
0 Participants
n=8 Participants • Data analysis only for a subset of patients with HCC undergoing hepatic resection compared to healthy controls.
|
0 Participants
n=40 Participants • Data analysis only for a subset of patients with HCC undergoing hepatic resection compared to healthy controls.
|
|
SubStudy 1: Race
Black or African American
|
12 Participants
n=32 Participants • Data analysis only for a subset of patients with HCC undergoing hepatic resection compared to healthy controls.
|
1 Participants
n=8 Participants • Data analysis only for a subset of patients with HCC undergoing hepatic resection compared to healthy controls.
|
13 Participants
n=40 Participants • Data analysis only for a subset of patients with HCC undergoing hepatic resection compared to healthy controls.
|
|
SubStudy 1: Race
White
|
16 Participants
n=32 Participants • Data analysis only for a subset of patients with HCC undergoing hepatic resection compared to healthy controls.
|
4 Participants
n=8 Participants • Data analysis only for a subset of patients with HCC undergoing hepatic resection compared to healthy controls.
|
20 Participants
n=40 Participants • Data analysis only for a subset of patients with HCC undergoing hepatic resection compared to healthy controls.
|
|
SubStudy 1: Race
More than one race
|
0 Participants
n=32 Participants • Data analysis only for a subset of patients with HCC undergoing hepatic resection compared to healthy controls.
|
0 Participants
n=8 Participants • Data analysis only for a subset of patients with HCC undergoing hepatic resection compared to healthy controls.
|
0 Participants
n=40 Participants • Data analysis only for a subset of patients with HCC undergoing hepatic resection compared to healthy controls.
|
|
SubStudy 1: Race
Unknown or Not Reported
|
1 Participants
n=32 Participants • Data analysis only for a subset of patients with HCC undergoing hepatic resection compared to healthy controls.
|
0 Participants
n=8 Participants • Data analysis only for a subset of patients with HCC undergoing hepatic resection compared to healthy controls.
|
1 Participants
n=40 Participants • Data analysis only for a subset of patients with HCC undergoing hepatic resection compared to healthy controls.
|
|
SubStudy 2: Age
|
68 years
n=24 Participants • Data results only for patients with unresectable HCC treated with Yttrium 90 radioembolization
|
—
|
68 years
n=24 Participants • Data results only for patients with unresectable HCC treated with Yttrium 90 radioembolization
|
|
SubStudy 2: Sex
Female
|
6 Participants
n=24 Participants • Data results only for patients with unresectable HCC treated with Yttrium 90 radioembolization
|
—
|
6 Participants
n=24 Participants • Data results only for patients with unresectable HCC treated with Yttrium 90 radioembolization
|
|
SubStudy 2: Sex
Male
|
18 Participants
n=24 Participants • Data results only for patients with unresectable HCC treated with Yttrium 90 radioembolization
|
—
|
18 Participants
n=24 Participants • Data results only for patients with unresectable HCC treated with Yttrium 90 radioembolization
|
|
SubStudy 2: Ethnicity
Hispanic or Latino
|
10 Participants
n=24 Participants • Data results only for patients with unresectable HCC treated with Yttrium 90 radioembolization
|
—
|
10 Participants
n=24 Participants • Data results only for patients with unresectable HCC treated with Yttrium 90 radioembolization
|
|
SubStudy 2: Ethnicity
Not Hispanic or Latino
|
12 Participants
n=24 Participants • Data results only for patients with unresectable HCC treated with Yttrium 90 radioembolization
|
—
|
12 Participants
n=24 Participants • Data results only for patients with unresectable HCC treated with Yttrium 90 radioembolization
|
|
SubStudy 2: Ethnicity
Unknown or Not Reported
|
2 Participants
n=24 Participants • Data results only for patients with unresectable HCC treated with Yttrium 90 radioembolization
|
—
|
2 Participants
n=24 Participants • Data results only for patients with unresectable HCC treated with Yttrium 90 radioembolization
|
|
SubStudy 2: Race
American Indian or Alaska Native
|
0 Participants
n=24 Participants • Data results only for patients with unresectable HCC treated with Yttrium 90 radioembolization
|
—
|
0 Participants
n=24 Participants • Data results only for patients with unresectable HCC treated with Yttrium 90 radioembolization
|
|
SubStudy 2: Race
Asian
|
1 Participants
n=24 Participants • Data results only for patients with unresectable HCC treated with Yttrium 90 radioembolization
|
—
|
1 Participants
n=24 Participants • Data results only for patients with unresectable HCC treated with Yttrium 90 radioembolization
|
|
SubStudy 2: Race
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=24 Participants • Data results only for patients with unresectable HCC treated with Yttrium 90 radioembolization
|
—
|
0 Participants
n=24 Participants • Data results only for patients with unresectable HCC treated with Yttrium 90 radioembolization
|
|
SubStudy 2: Race
Black or African American
|
6 Participants
n=24 Participants • Data results only for patients with unresectable HCC treated with Yttrium 90 radioembolization
|
—
|
6 Participants
n=24 Participants • Data results only for patients with unresectable HCC treated with Yttrium 90 radioembolization
|
|
SubStudy 2: Race
White
|
15 Participants
n=24 Participants • Data results only for patients with unresectable HCC treated with Yttrium 90 radioembolization
|
—
|
15 Participants
n=24 Participants • Data results only for patients with unresectable HCC treated with Yttrium 90 radioembolization
|
|
SubStudy 2: Race
More than one race
|
0 Participants
n=24 Participants • Data results only for patients with unresectable HCC treated with Yttrium 90 radioembolization
|
—
|
0 Participants
n=24 Participants • Data results only for patients with unresectable HCC treated with Yttrium 90 radioembolization
|
|
SubStudy 2: Race
Unknown or Not Reported
|
2 Participants
n=24 Participants • Data results only for patients with unresectable HCC treated with Yttrium 90 radioembolization
|
—
|
2 Participants
n=24 Participants • Data results only for patients with unresectable HCC treated with Yttrium 90 radioembolization
|
PRIMARY outcome
Timeframe: Day 1Population: Data analysis only for a subset of patients with HCC undergoing hepatic resection
Tumor diffusion (apparent diffusion coefficient) measured with diffusion-weighted imaging sequence
Outcome measures
| Measure |
Hepatocellular Carcinoma (HCC)
n=32 Participants
Participants with hepatocellular carcinoma (HCC)
|
Healthy Participant
Healthy control participants
|
|---|---|---|
|
SubStudy 1: Apparent Diffusion Coefficient (ADC)
|
1.43 1x10^-3 mm^2/s
Standard Deviation 0.68
|
—
|
PRIMARY outcome
Timeframe: Day 1Population: Data analysis only for a subset of patients with HCC undergoing hepatic resection
Perfusion/flow measured with dynamic contrast-enhanced imaging using gadolinium contrast
Outcome measures
| Measure |
Hepatocellular Carcinoma (HCC)
n=32 Participants
Participants with hepatocellular carcinoma (HCC)
|
Healthy Participant
Healthy control participants
|
|---|---|---|
|
SubStudy 1: Total Tumor Perfusion (Ft)
|
358 ml/min/100g
Standard Deviation 337
|
—
|
PRIMARY outcome
Timeframe: Day 1Population: Data analysis only for a subset of patients with HCC undergoing hepatic resection
Perfusion/flow measured with dynamic contrast-enhanced imaging using gadolinium contrast
Outcome measures
| Measure |
Hepatocellular Carcinoma (HCC)
n=32 Participants
Participants with hepatocellular carcinoma (HCC)
|
Healthy Participant
Healthy control participants
|
|---|---|---|
|
SubStudy 1: Tumor Arterial Perfusion Fraction (ART)
|
78.9 percent of perfusion
Standard Deviation 21.5
|
—
|
PRIMARY outcome
Timeframe: Day 1Population: Data analysis only for a subset of patients with HCC undergoing hepatic resection
Tumor mean transit time (MTT) of contrast agent. Perfusion/flow measured with dynamic contrast-enhanced imaging using gadolinium contrast
Outcome measures
| Measure |
Hepatocellular Carcinoma (HCC)
n=32 Participants
Participants with hepatocellular carcinoma (HCC)
|
Healthy Participant
Healthy control participants
|
|---|---|---|
|
SubStudy 1: Tumor Mean Transit Time (MTT)
|
21.2 sec
Standard Deviation 15.8
|
—
|
PRIMARY outcome
Timeframe: Day 1Population: Data analysis only for a subset of patients with HCC undergoing hepatic resection
Tumor distribution volume (DV) of contrast agent. Perfusion/flow measured with dynamic contrast-enhanced imaging using gadolinium contrast
Outcome measures
| Measure |
Hepatocellular Carcinoma (HCC)
n=32 Participants
Participants with hepatocellular carcinoma (HCC)
|
Healthy Participant
Healthy control participants
|
|---|---|---|
|
SubStudy 1: Tumor Distribution Volume (DV)
|
34.6 percent
Standard Deviation 24.7
|
—
|
PRIMARY outcome
Timeframe: Day 1Population: Data analysis only for a subset of patients with HCC undergoing hepatic resection compared to healthy controls. Oxygen uptake for HCCs is reported in patients, and oxygen uptake for the liver is reported in volunteers. R1 measurements method in the volunteers proved unreliable - therefore no data available for T1/R1 in the healthy participant arm.
Oxygen uptake measured with T2\* and T1-weighted imaging
Outcome measures
| Measure |
Hepatocellular Carcinoma (HCC)
n=32 Participants
Participants with hepatocellular carcinoma (HCC)
|
Healthy Participant
n=8 Participants
Healthy control participants
|
|---|---|---|
|
SubStudy 1: Oxygen Uptake
R2*(=1/T2*) pre oxygen (O2) administration
|
34.6 s-1
Standard Deviation 24.7
|
33.2 s-1
Standard Deviation 5.8
|
|
SubStudy 1: Oxygen Uptake
R2* post O2
|
33.7 s-1
Standard Deviation 14.5
|
30.7 s-1
Standard Deviation 5.2
|
|
SubStudy 1: Oxygen Uptake
ΔR2*=R2* post O2-R2* pre O2
|
-0.78 s-1
Standard Deviation 8.7
|
—
|
|
SubStudy 1: Oxygen Uptake
R1(=1/T1) pre oxygen (O2) administration
|
1.67 s-1
Standard Deviation 0.94
|
—
|
|
SubStudy 1: Oxygen Uptake
R1 post O2
|
1.90 s-1
Standard Deviation 1.79
|
—
|
|
SubStudy 1: Oxygen Uptake
ΔR1=R1 post O2-R1 pre O2
|
0.23 s-1
Standard Deviation 1.1
|
—
|
PRIMARY outcome
Timeframe: Day 1, pre-oxygen administration and 10 min. post-oxygen administrationPopulation: Healthy Participants only
Oxygen uptake measured with T2\* and T1-weighted imaging. Oxygen uptake (% change pre and post O2 administration) calculated by Liver ΔR2\*=100 x (R2\* post O2-R2\* pre O2)/R2\* pre O2. The healthy participants breathed 100% medical O2 through a mask for 10 min., and were imaged before and after O2 administration with the MRI methods that are sensitive to oxygen uptake in tumors.
Outcome measures
| Measure |
Hepatocellular Carcinoma (HCC)
Participants with hepatocellular carcinoma (HCC)
|
Healthy Participant
n=8 Participants
Healthy control participants
|
|---|---|---|
|
SubStudy 1: Percent Change in Oxygen Uptake
|
—
|
7.2 percent of oxygen uptake
Standard Deviation 7.9
|
PRIMARY outcome
Timeframe: baseline and 6 weeks after Y90Population: Data results only for patients with unresectable HCC treated with Yttrium 90 radioembolization
Tumor diffusion measured with diffusion-weighted imaging sequence. In diffusion weighted MR imaging (DWI), the signal is proportional to the Brownian motion diffusion of free water protons in tissues. Deposition of collagen in tissue (as in fibrotic disease), or cellularity in tumors act as impediments to free water diffusion. Using different mathematical models, the degree of diffusion can be quantified from the MRI signal, to provide information on diffusion restriction due to disease. From mono exponential fit of diffusion signal, one can obtain the apparent diffusion coefficient (ADC). However, this coefficient reflects free water proton diffusion, as well as transport of water protons in the capillary vessels (capillary perfusion).
Outcome measures
| Measure |
Hepatocellular Carcinoma (HCC)
n=24 Participants
Participants with hepatocellular carcinoma (HCC)
|
Healthy Participant
Healthy control participants
|
|---|---|---|
|
SubStudy 2: ADC
Baseline
|
1.28 1x10^-3 mm^2/s
Standard Deviation 0.22
|
—
|
|
SubStudy 2: ADC
6 weeks post y90
|
1.62 1x10^-3 mm^2/s
Standard Deviation 0.24
|
—
|
PRIMARY outcome
Timeframe: baseline and 6 weeks after Y90Population: Data results only for patients with unresectable HCC treated with Yttrium 90 radioembolization
Tumor diffusion measured with diffusion-weighted imaging sequence. To separate the diffusion effect from capillary perfusion, a bi-exponential model is used, which provides 3 coefficients: one is the true diffusion coefficient D, reflecting free water proton diffusion.
Outcome measures
| Measure |
Hepatocellular Carcinoma (HCC)
n=24 Participants
Participants with hepatocellular carcinoma (HCC)
|
Healthy Participant
Healthy control participants
|
|---|---|---|
|
SubStudy 2: Diffusion Coefficient D
Baseline
|
1.12 1x10^-3 mm^2/s
Standard Deviation 0.19
|
—
|
|
SubStudy 2: Diffusion Coefficient D
6 weeks post y90
|
1.33 1x10^-3 mm^2/s
Standard Deviation 0.23
|
—
|
PRIMARY outcome
Timeframe: baseline and 6 weeks after Y90Population: Data results only for patients with unresectable HCC treated with Yttrium 90 radioembolization
Tumor diffusion measured with diffusion-weighted imaging sequence. To separate the diffusion effect from capillary perfusion, a bi-exponential model is used, which provides 3 coefficients: one is the pseudo-diffusion coefficient D\*, affected by free diffusion and capillary perfusion.
Outcome measures
| Measure |
Hepatocellular Carcinoma (HCC)
n=24 Participants
Participants with hepatocellular carcinoma (HCC)
|
Healthy Participant
Healthy control participants
|
|---|---|---|
|
SubStudy 2: Pseudodiffusion Coefficient D*
Baseline
|
41.16 1x10^-3 mm^2/s
Standard Deviation 35.73
|
—
|
|
SubStudy 2: Pseudodiffusion Coefficient D*
6 weeks post y90
|
30.1 1x10^-3 mm^2/s
Standard Deviation 14.99
|
—
|
PRIMARY outcome
Timeframe: baseline and 6 weeks after Y90Population: Data results only for patients with unresectable HCC treated with Yttrium 90 radioembolization
Tumor diffusion measured with diffusion-weighted imaging sequence. To separate the diffusion effect from capillary perfusion, a bi-exponential model is used, which provides 3 coefficients: one is the perfusion fraction PF, which reflects how much the diffusion-weighted signal is affected by capillary perfusion. PF is a measure of vascularity in the tissue.
Outcome measures
| Measure |
Hepatocellular Carcinoma (HCC)
n=24 Participants
Participants with hepatocellular carcinoma (HCC)
|
Healthy Participant
Healthy control participants
|
|---|---|---|
|
SubStudy 2: Perfusion Fraction (PF)
Baseline
|
22.9 1x10^-3 mm^2/s
Standard Deviation 11.57
|
—
|
|
SubStudy 2: Perfusion Fraction (PF)
6 weeks post y90
|
21.9 1x10^-3 mm^2/s
Standard Deviation 9.43
|
—
|
SECONDARY outcome
Timeframe: baseline and 6 weeks after Y90Population: Data results only for patients with unresectable HCC treated with Yttrium 90 radioembolization
Perfusion/flow measured with dynamic contrast-enhanced imaging using gadolinium contrast
Outcome measures
| Measure |
Hepatocellular Carcinoma (HCC)
n=24 Participants
Participants with hepatocellular carcinoma (HCC)
|
Healthy Participant
Healthy control participants
|
|---|---|---|
|
SubStudy 2: Total Tumor Perfusion (Ft)
Baseline
|
64.44 ml/min/100g tissue
Standard Deviation 52.77
|
—
|
|
SubStudy 2: Total Tumor Perfusion (Ft)
6 weeks post y90
|
49.12 ml/min/100g tissue
Standard Deviation 58.59
|
—
|
SECONDARY outcome
Timeframe: baseline and 6 weeks after Y90Population: Data results only for patients with unresectable HCC treated with Yttrium 90 radioembolization
Perfusion/flow measured with dynamic contrast-enhanced imaging using gadolinium contrast
Outcome measures
| Measure |
Hepatocellular Carcinoma (HCC)
n=24 Participants
Participants with hepatocellular carcinoma (HCC)
|
Healthy Participant
Healthy control participants
|
|---|---|---|
|
SubStudy 2: Tumor Arterial Perfusion Fraction (ART)
Baseline
|
76.92 percent of perfusion
Standard Deviation 16.87
|
—
|
|
SubStudy 2: Tumor Arterial Perfusion Fraction (ART)
6 weeks post y90
|
52.17 percent of perfusion
Standard Deviation 24.53
|
—
|
SECONDARY outcome
Timeframe: baseline and 6 weeks after Y90Population: Data results only for patients with unresectable HCC treated with Yttrium 90 radioembolization
Perfusion/flow measured with dynamic contrast-enhanced imaging using gadolinium contrast
Outcome measures
| Measure |
Hepatocellular Carcinoma (HCC)
n=24 Participants
Participants with hepatocellular carcinoma (HCC)
|
Healthy Participant
Healthy control participants
|
|---|---|---|
|
SubStudy 2: Tumor Mean Transit Time (MTT) of Contrast Agent
6 weeks post y90
|
27.86 sec
Standard Deviation 12.05
|
—
|
|
SubStudy 2: Tumor Mean Transit Time (MTT) of Contrast Agent
Baseline
|
27 sec
Standard Deviation 13.01
|
—
|
SECONDARY outcome
Timeframe: baseline and 6 weeks after Y90Population: Data results only for patients with unresectable HCC treated with Yttrium 90 radioembolization
Perfusion/flow measured with dynamic contrast-enhanced imaging using gadolinium contrast. Extravascular extracellular volume fraction ve (%) - represents the portion of tissue occupied by the extravascular extracellular volume (interstitial space), in which MRI contrast agent can distribute.
Outcome measures
| Measure |
Hepatocellular Carcinoma (HCC)
n=24 Participants
Participants with hepatocellular carcinoma (HCC)
|
Healthy Participant
Healthy control participants
|
|---|---|---|
|
SubStudy 2: Extravascular Extracellular Volume ve
Baseline
|
16.77 percent of perfusion
Standard Deviation 6.44
|
—
|
|
SubStudy 2: Extravascular Extracellular Volume ve
6 weeks post y90
|
10.27 percent of perfusion
Standard Deviation 7.39
|
—
|
SECONDARY outcome
Timeframe: baseline and 6 weeks after Y90Population: Data results only for patients with unresectable HCC treated with Yttrium 90 radioembolization. Excluded: 3 treated with other therapies, 2 deceased before 6 weeks follow-up.
measured with magnetic resonance elastography
Outcome measures
| Measure |
Hepatocellular Carcinoma (HCC)
n=24 Participants
Participants with hepatocellular carcinoma (HCC)
|
Healthy Participant
Healthy control participants
|
|---|---|---|
|
Substudy 2: Tumor Stiffness
Baseline
|
5.0 kilo Pascals (kPa)
Standard Deviation 2.5
|
—
|
|
Substudy 2: Tumor Stiffness
6 weeks post y90
|
7.0 kilo Pascals (kPa)
Standard Deviation 3.8
|
—
|
SECONDARY outcome
Timeframe: 6 weeks and 6-12 monthsPopulation: Data results only for patients with unresectable HCC treated with Yttrium 90 radioembolization.
Tumor response to treatment is evaluated clinically by radiologists according to RECIST and modified RECIST criteria, by which the diameter of the tumor portion that enhances (lights up on imaging) after administration of gadolinium contrast agent is measured before and after treatment. The response is not reported as diameter or diameter difference in mm, but rather as a qualitative variable: complete response, partial response, stable disease and progressive disease. Complete response means no enhancing tumor regions after treatment (i.e. complete tumor necrosis, no more vascular regions of the tumor that take up contrast), partial response is a decrease in the diameter of the enhancing region, stable disease is unchanged diameter, and progressive disease is an increase in the diameter of the enhancing region after treatment.
Outcome measures
| Measure |
Hepatocellular Carcinoma (HCC)
n=25 lesions
Participants with hepatocellular carcinoma (HCC)
|
Healthy Participant
n=18 lesions
Healthy control participants
|
|---|---|---|
|
Tumor Response
Stable Disease
|
8 lesions
|
0 lesions
|
|
Tumor Response
Complete Response
|
11 lesions
|
14 lesions
|
|
Tumor Response
Partial Response
|
6 lesions
|
4 lesions
|
Adverse Events
Healthy Participant
SubStudy 1
SubStudy 2
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Healthy Participant
n=8 participants at risk
Healthy control participants
|
SubStudy 1
n=32 participants at risk
Data analysis only for a subset of patients with HCC undergoing hepatic resection compared to healthy controls
|
SubStudy 2
n=24 participants at risk
Data results only for patients with unresectable HCC treated with Yttrium 90 radioembolization
|
|---|---|---|---|
|
General disorders
Mild contrast reaction
|
0.00%
0/8 • 6 weeks
|
6.2%
2/32 • 6 weeks
|
0.00%
0/24 • 6 weeks
|
|
Product Issues
Unable to tolerate carbogen
|
0.00%
0/8 • 6 weeks
|
3.1%
1/32 • 6 weeks
|
0.00%
0/24 • 6 weeks
|
|
Eye disorders
Left eye pain
|
12.5%
1/8 • 6 weeks
|
0.00%
0/32 • 6 weeks
|
0.00%
0/24 • 6 weeks
|
Additional Information
Dr. Bachir Taouli
Icahn School of Medicine at Mount Sinai
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place