N/A
N=84
Evaluation of Liver Cancer With Magnetic Resonance Imaging (MRI)
Hepatocellular Carcinoma · HCC
Bottom Line
View on ClinicalTrials.gov: NCT01871545 ↗Enrolled (actual)
84
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcome: Primary: SubStudy 1: Apparent Diffusion Coefficient (ADC) — 1.43 1x10^-3 mm^2/s
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Magnetic Resonance Imaging (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY SubStudy 1: Apparent Diffusion Coefficient (ADC) |
1.43 | — |
| PRIMARY SubStudy 1: Total Tumor Perfusion (Ft) |
358 | — |
| PRIMARY SubStudy 1: Tumor Arterial Perfusion Fraction (ART) |
78.9 | — |
| PRIMARY SubStudy 1: Tumor Mean Transit Time (MTT) |
21.2 | — |
| PRIMARY SubStudy 1: Tumor Distribution Volume (DV) |
34.6 | — |
| PRIMARY SubStudy 1: Oxygen Uptake |
34.6; 33.2; 33.7; 30.7; -0.78; 1.67 | — |
| PRIMARY SubStudy 1: Percent Change in Oxygen Uptake |
7.2 | — |
| PRIMARY SubStudy 2: ADC |
1.28; 1.62 | — |
| PRIMARY SubStudy 2: Diffusion Coefficient D |
1.12; 1.33 | — |
| PRIMARY SubStudy 2: Pseudodiffusion Coefficient D* |
41.16; 30.1 | — |
| PRIMARY SubStudy 2: Perfusion Fraction (PF) |
22.9; 21.9 | — |
| SECONDARY SubStudy 2: Total Tumor Perfusion (Ft) |
64.44; 49.12 | — |
| SECONDARY SubStudy 2: Tumor Arterial Perfusion Fraction (ART) |
76.92; 52.17 | — |
| SECONDARY SubStudy 2: Tumor Mean Transit Time (MTT) of Contrast Agent |
27; 27.86 | — |
| SECONDARY SubStudy 2: Extravascular Extracellular Volume ve |
16.77; 10.27 | — |
| SECONDARY Substudy 2: Tumor Stiffness |
5.0; 7.0 | — |
| SECONDARY Tumor Response |
8; 0; 6; 4; 11; 14 | — |
Summary
The incidence of hepatocellular carcinoma (HCC) has recently increased in the United States. Although imaging plays a major role in HCC screening and staging, the possibility of predicting HCC tumor grade, aggressiveness, angiogenesis and hypoxia with imaging are unmet needs. In addition, new antiangiogenic drugs now available to treat advanced HCC necessitate the use of new imaging criteria beyond size. The investigators would like to develop and validate non-invasive magnetic resonance imaging (MRI) methods based on advanced diffusion-weighted imaging (DWI), MR Elastography, BOLD (blood oxygen level dependent) MRI and perfusion-weighted imaging (PWI, using gadolinium contrast) to be used as non-invasive markers of major histopathologic features of HCC, and to predict and assess early response of HCC to systemic therapy. The investigators also would like to develop quality control tools to improve the quality and decrease variability of quantitative MRI metrics. These techniques combined could represent non-invasive correlates of histologic findings in HCC, could enable individualized therapy, and provide prognosis in patients with HCC.
Eligibility Criteria
Inclusion Criteria
Study group
- Patients diagnosed with HCC, who will undergo resection or transplantation within 6 months, as part of routine clinical care and patients diagnosed with unresectable HCC
- 18 years of age and older
- Patient is able to give informed consent for this study
Control group
- Healthy volunteers 18 years of age and older
- Subject is able to give informed consent for this study
Exclusion Criteria
- Age less than 18 years
- Unable or unwilling to give informed consent
- Contra-indications to MRI:
- Electrical implants such as cardiac pacemakers or perfusion pumps
- Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants
- Ferromagnetic objects such as jewelry or metal clips in clothing
- Pregnant subjects
- Pre-existing medical conditions including a likelihood of developing seizures or claustrophobic reactions
Data sourced from ClinicalTrials.gov (NCT01871545). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.