Surefire QED

Principal Investigator: Ryan  O'Hara
Keywords: DEB-TACE , Hepatic Artery Embolization , Catheter Department: Radiology Clinical
IRB Number: 00091889 Co Investigator: Ziga Cizman
Specialty: Radiology
Sub Specialties: Interventional Radiology
Recruitment Status: Recruiting

Contact Information

Collin Arsenault
(801) 587-8638

Brief Summary

Primary Objective
To determine objective tumor response at one-month post-DEB-TACE procedure measured by modified RECIST (mRECIST) criteria 12. Objective response is defined as complete response plus partial response (Appendix D).
Secondary Objectives
  • Subject’s three-month tumor response rate (or 1 month if DEB-TACE retreatment performed)
  • Response rate assessed by individual tumor (1-month retreatment or 3 months)
  • Dose delivered to the tumors
  • Post TACE ConeBeam CT measurement of contrast retention in tumor (Hounsfield Units (HU))
  • Contrast dose
  • Fluoroscopic time
  • Number of Repeat Procedures per lesion
  • Changes in AFP levels

Inclusion Criteria

Inclusion Criteria 

1. Patients aged 18 years or older, inclusive 

2. Diagnosis of HCC; 

3. Meets UCSF14 criteria: a single lesion ≤ 6.5 cm in diameter or 2-3 lesions ≤ 4.5 cm with total tumor diameter ≤ 8 cm; 

4. No portal invasion or extrahepatic spread on imaging; 

5. Child-Pugh Class15 A or B; 

6. No previous chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy); 

7. An Eastern Cooperative Oncology Group (ECOG)13 performance status of 0 or 1; 

8. A discrete hepatic artery(s) feeding the tumor with diameter of the vessel(s) ≥ 1.5 mm. 

Exclusion Criteria

Exclusion Criteria 

1. Bilirubin levels >3 mg/dl 

2. AST or ALT >5 times upper limit of normal or >250 U/l; 

3. Advanced tumoral disease (vascular invasion or extrahepatic spread, portal vein thrombosis of bland or malignant origin), or diffuse HCC, defined as 50% liver involvement; 

4. Contraindications for doxorubicin administration; 

5. Subject has a known history contraindicating contrast dye or iodine that cannot be safely controlled via antihistamine, steroids, or with any other agent; 

6. Unable or unwilling to provide informed consent; 

7. Women who are pregnant or breast feeding; 

8. Women of childbearing potential who are not using an acceptable method of birth control (e.g., pill, patch, IUD, ring, condom, sponge, foam); 

9. Portal vein thrombosis of bland or malignant origin.