Clinical trial NCT02173119: Can Quantitative MRI After cTACE Help Predict Survival ?
Official title: Can Quantitative MRI After Conventional Transarterial Chemoembolization (cTACE) Help Predict Survival ?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma (HCC)
Keywords: Hepatocellular
Carcinoma
HCC
lipiodol
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Guerbet
name: Northwestern University
First posted: 2014-06-24
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Imaging response
timeFrame: Every 4-6 weeks during active treatment and then every 3-6 months, up to 5 years or death.
Secondary outcomes:
measure: Clinical response
timeFrame: Every 4-6 weeks during active treatment and then every 3-6 months, up to 5 years or death.
measure: Adverse Events
timeFrame: Every 4-6 weeks during active treatment and then every 3-6 months, up to 5 years or death.
measure: Time-to-Tumor Progression
timeFrame: Every 4-6 weeks during active treatment and then every 3-6 months, up to 5 years or death.
measure: Survival
timeFrame: Every 4-6 weeks during active treatment and then every 3-6 months, up to 5 years or death.
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin/Froedtert Memorial Lutheran Hospital
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Sarah B. White, MD
role: PRINCIPAL_INVESTIGATOR
References: