Clinical trial NCT03345225: A Clinical Study of Precision TACE (P-TACE) With Surefire
Official title: A Randomized Clinical Study of Precision TACE (P-TACE) With Surefire Infusion Catheter Versus Standard Endhole Catheter (E-TACE) Utilizing Radiopaque Drug Eluting Beads (LUMI) in Patients With Hepatocellular Carcinoma (HCC)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Unresectable Hepatocellular Carcinoma
Keywords: Chemoembolization (TACE)
HCC
Liver Cancer
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Surefire Medical, Inc.
First posted: 2017-11-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The purpose of this research study is to learn about 2 types of FDA-approved catheters used in angiographic (X-ray of blood vessels, with radiopaque substance) procedures like DEB-TACE treatment. The Principal Investigator will check the beads given during the DEB-TACE. They will compare the way in which they are spread out in the tumor and density (how condensed something is).


Eligibility criteria: Inclusion Criteria:

1. Patients \> 18 years with confirmed diagnosis of unresectable hepatocellular carcinoma who are candidates for TACE therapy
2. Barcelona Clinic Liver Cancer Classification (BCLC) A or B
3. Child-Pugh Class A or B
4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
5. 1 to 5 target tumors that are \< 6cm with at least one tumor ≥ 3cm in size
6. Vessel size ≥ 1.5 mm
7. Subject must be able to provide written informed consent

Exclusion Criteria:

1. Extra-hepatic spread of the cancer
2. Macrovascular tumor invasion
3. Diffuse HCC (\>50% liver involvement)
4. Previous chemotherapy, radiotherapy, transarterial embolization or ablations in the targeted tumor(s)
5. Advanced liver disease (bilirubin \> 3 mg/dl, aspartate aminotransferase (AST) or ALT \> 5x upper limit of normal or \> 250 U/I
6. Extrahepatic supply to the tumor
7. Hypovascular tumors
8. Heart failure with reduced ejection fraction or Left Ventricular Ejection Fraction (LVEF) ≤ 40 percent
9. Any serious medical or psychiatric illness/condition that will interfere or limit compliance with study requirements/treatments.

Primary outcomes:
measure: Comparing the change in the Lencioni score between the SureFire infusion system and a standard endhole microcatheter
timeFrame: 1 month
Secondary outcomes:
measure: The Lencioni Score (LS)
timeFrame: 3 months
measure: The Lencioni Score (LS)
timeFrame: 6 months
measure: Objective Response Rate as measured by mRECIST
timeFrame: 1 Month
measure: Objective Response Rate as measured by mRECIST
timeFrame: 3 Month
measure: Objective Response Rate as measured by mRECIST
timeFrame: 6 Month
measure: Distribution of Radiopaque beads
timeFrame: 1 Month
measure: Distribution of Radiopaque beads
timeFrame: 3 Month
measure: Distribution of Radiopaque beads
timeFrame: 6 Month
measure: Tumor enhancement
timeFrame: 1 month
measure: Tumor enhancement
timeFrame: 3 month
measure: Tumor enhancement
timeFrame: 6 month
measure: Number of Adverse Event
timeFrame: 6 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Shree Venkat, MD
role: PRINCIPAL_INVESTIGATOR
References: