Can Quantitative MRI After cTACE Help Predict Survival ?

Completed

• Conditions: Hepatocellular Carcinoma (HCC)
• Interventions: Other: MRI post-TACE

• Registration Number: NCT02173119
• Lead Sponsor: Medical College of Wisconsin

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-17
• Study First Submitted QC: 2014-06-20
• Study First Posted: 2014-06-24
• Study Start: 2014-08
• Primary Completion: 2018-03-07
• Study Completion: 2018-03-07
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-06
• Last Update Posted: 2019-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HCC patients having MRI post-TACE	MRI post-TACE	HCC patients who have undergone conventional lipiodol based chemoembolization.

Primary Outcome Measures

Name	Time	Method
Imaging response	Every 4-6 weeks during active treatment and then every 3-6 months, up to 5 years or death.	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.

Secondary Outcome Measures

Name	Time	Method
Adverse Events	Every 4-6 weeks during active treatment and then every 3-6 months, up to 5 years or death.	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.
Clinical response	Every 4-6 weeks during active treatment and then every 3-6 months, up to 5 years or death.	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.
Survival	Every 4-6 weeks during active treatment and then every 3-6 months, up to 5 years or death.	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.
Time-to-Tumor Progression	Every 4-6 weeks during active treatment and then every 3-6 months, up to 5 years or death.	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).

Trial Locations

Locations (1)

Medical College of Wisconsin/Froedtert Memorial Lutheran Hospital; 🇺🇸 Milwaukee, Wisconsin, United States