Skip to main content
OpenTrials
Completed

NCT Number: NCT02173119

Can Quantitative MRI After 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hepatocellular Carcinoma (HCC) Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical College of Wisconsin/Froedtert Memorial Lutheran Hospital

Milwaukee, Wisconsin, 53226, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MRI post-TACE

Other

Perform lipiodol delivery measurements with MRI post-TACE.

Primary outcomes

  1. Imaging response

    Time frame: 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 outcomes

  1. Clinical response

    Time frame: 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.

  2. Adverse Events

    Time frame: 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.

  3. Time-to-Tumor Progression

    Time frame: 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).

  4. Survival

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Collaborators

  • Guerbet
  • Northwestern University

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jun 24, 2014
Registry last updated
Jun 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.