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Magnetic Resonance Imaging for Hepatocellular Carcinoma

N/A
Waitlist Available
Led By Bachir Taouli, MD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks and 6-12 months
Awards & highlights

Study 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.

Eligible Conditions
  • Hepatocellular Carcinoma
  • Liver Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks and 6-12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks and 6-12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
SubStudy 1: Apparent Diffusion Coefficient (ADC)
SubStudy 1: Oxygen Uptake
SubStudy 1: Percent Change in Oxygen Uptake
+8 more
Secondary outcome measures
Extravascular Lung Water
SubStudy 2: Total Tumor Perfusion (Ft)
SubStudy 2: Tumor Arterial Perfusion Fraction (ART)
+3 more

Side effects data

From 2022 Phase 3 trial • 53 Patients • NCT00033293
19%
87900-Vomiting(targeted toxicity)
15%
11400-Agitation
8%
11600-Alanine aminotransferase increased
8%
16800-Bladder infection
8%
44800-Infections and infestations - Other specify
8%
58700-Nystagmus
4%
15000-Aspartate aminotransferase increased
4%
88500-White blood cell decreased
4%
15300-Ataxia
4%
33900-Fever
4%
25700-Diarrhea
4%
43100-Hypokalemia
4%
69700-Rash maculo-papular(targeted toxicity)
4%
13200-Anemia
4%
33300-Febrile neutropenia
4%
57600-Nausea(targeted toxicity)
4%
20500-Catheter related infection
4%
58300-Neutrophil count decreased
4%
41300-Hypercalcemia
4%
41400-Hyperglycemia(targeted toxicity)
4%
41600-Hyperkalemia
4%
42600-Hypoalbuminemia
4%
42700-Hypocalcemia
4%
64400-Personality change
4%
41500-Hyperhidrosis
4%
13500-Anorexia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm I (Chemotherapy, Immunoglobulin Therapy)
Arm II (Chemotherapy, Observation)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Magnetic Resonance ImagingExperimental Treatment1 Intervention
dynamic contrast-enhanced MRI measuring arterial and portal flow
Group II: Healthy ControlsActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
871 Previous Clinical Trials
527,179 Total Patients Enrolled
6 Trials studying Hepatocellular Carcinoma
1,104 Patients Enrolled for Hepatocellular Carcinoma
Bachir Taouli, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
2 Previous Clinical Trials
345 Total Patients Enrolled
~7 spots leftby Jun 2025