Can Quantitative MRI After cTACE Help Predict Survival ?

Hepatocellular Carcinoma (HCC) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02173119
• Other study ID #: PRO22746
• Status: Completed
• Start date: August 2014
• Est. completion date: March 7, 2018

Study information

• Verified date: June 2019
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: March 7, 2018
• Est. primary completion date: March 7, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma (HCC)

Intervention

Other:
• MRI post-TACE
Perform lipiodol delivery measurements with MRI post-TACE.

Locations

Country	Name	City	State
United States	Medical College of Wisconsin/Froedtert Memorial Lutheran Hospital	Milwaukee	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
Medical College of Wisconsin	Guerbet, Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.