Can Quantitative MRI After cTACE Help Predict Survival ?

Can Quantitative MRI After Conventional Transarterial Chemoembolization (cTACE) Help Predict Survival ?

Transcatheter arterial chemoembolization (TACE) is a widely accepted palliative therapy for the treatment of HCC. Palliative means that it does not cure the disease prolongs your life and improves quality of life. During TACE, a mixture of chemotherapy drugs is combined with an oil called lipiodol. Lipiodol has a role as both drug carrier and embolic agent (a material that blocks blood flow to tumors). The lipiodol/chemotherapy mixture is injected into an artery (blood vessel) directly supplying blood to a HCC tumor.

Lipiodol is made up of fat and water which can be seen on MRI. Therefore, MRI can be used to quantify the amount of lipiodol delivered to the HCC tumors.

In this study, the investigators want to see if patient survival is related to the amount of lipiodol delivered to HCC tumors.

Study Overview

• Status: Completed
• Conditions: Hepatocellular Carcinoma (HCC)
• Intervention / Treatment: Other: MRI post-TACE

• Study Type: Observational
• Enrollment (Actual): 23

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin/Froedtert Memorial Lutheran Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with hepatocellular carcinoma (HCC or cancer of the liver) and will soon undergo one or more transcatheter arterial chemoembolization (TACE) procedure(s).

Description

Inclusion Criteria:

• Prospective studies will be performed in 20 patients with Hepatocellular Carcinoma (HCC) independently scheduled to undergo TACE; tumors in each of these candidates will already have been deemed un-resectable.

• Reasons may include

  • concurrent co-morbidities including cardiac or respiratory compromise
  • recurrent or multi-lobar disease
  • cirrhosis or portal hypertension
  • vascular invasion
  • high tumor burden
  • contraindications to general anesthesia.
• Diagnosis of HCC will have been established by a) biopsy or b) non-invasively, based upon > 2cm diameter tumor with characteristic imaging findings in the setting of cirrhosis.
• Male or female aged 18 to 89 years, all ethnicities

Exclusion Criteria:

• Infiltrative or diffuse HCC.
• Does not meet inclusion criteria.
• Pregnant women.
• Individuals with pacemakers or other non-MRI compatible metallic implants.
• Hemodialysis patients or patients with severely impaired renal function.
• Individuals with severe claustrophobia or unwilling to get a MRI.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HCC patients having MRI post-TACE; HCC patients who have undergone conventional lipiodol based chemoembolization.	Other: MRI post-TACE; Perform lipiodol delivery measurements with MRI post-TACE.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Imaging response	Imaging response will be assessed according to 3D European Association for the Study of the Liver (EASL) criteria. EASL criteria propose using contrast enhanced (CE) images to measure viable volumes. We will transfer all images to a computer workstation. We will measure 'viable' enhancing tumor volumes at each interval and percent change in viable tumor volume (change from baseline). We will correlate lipiodol delivery measurements to primary outcomes post-therapy.	Every 4-6 weeks during active treatment and then every 3-6 months, up to 5 years or death.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical response	Clinical response will be measured using Eastern Cooperative Oncology Group (ECOG) performance status classification. We will consider a change of 0.5 ECOG levels to be clinically significant.	Every 4-6 weeks during active treatment and then every 3-6 months, up to 5 years or death.
Adverse Events	Adverse Events will be measured according to the Common Terminology Criteria (NCI CTC) version 3.0 criteria for each patient. We will define Grades 0-2 as tolerance to therapy and Grades 3 or 4 as toxic.	Every 4-6 weeks during active treatment and then every 3-6 months, up to 5 years or death.
Time-to-Tumor Progression	Time-to-tumor progression will be assessed by monitoring viable tumor volumes post-TACE and defining progression as a >44% volume increase (3D EASL criteria).	Every 4-6 weeks during active treatment and then every 3-6 months, up to 5 years or death.
Survival	We will determine the number of days from first treatment to last follow-up to calculate the median days of overall survival after first treatment.	Every 4-6 weeks during active treatment and then every 3-6 months, up to 5 years or death.

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Collaborators: Northwestern University; Guerbet
• Investigators: Principal Investigator: Sarah B. White, MD, Medical College of Wisconsin

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): March 7, 2018
• Study Completion (Actual): March 7, 2018

Study Registration Dates

• First Submitted: June 17, 2014
• First Submitted That Met QC Criteria: June 20, 2014
• First Posted (Estimate): June 24, 2014

Study Record Updates

• Last Update Posted (Actual): June 10, 2019
• Last Update Submitted That Met QC Criteria: June 6, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: HCC; Carcinoma; Hepatocellular; lipiodol
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma, Hepatocellular
• Other Study ID Numbers: PRO22746

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No