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:

  • Patients aged 18 years or older with the diagnosis of HCC currently being evaluated for liver transplantation
  • Meets Milan Criteria: single tumor ≤ 5 cm, or maximum of 3 total tumors with each  3 cm AND/OR, meets UCSF criteria: a single lesion < 6.5 cm in diameter or 2-3 lesions < 4.5 cm with total tumor diameter < 8 cm
  • No portal invasion or extrahepatic spread on imaging
  • Child’s Class A or B
  • No previous chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy)
  • An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and preserved liver function (Child-Pugh Class A or B).
  • Has a discrete hepatic artery feeding the tumor with diameter of the vessels > 1.5 mm

Exclusion Criteria

Exclusion Criteria:

  • Advanced bilirubin levels > 3 mg/dl, AST or ALT > 5 times upper limit of normal or > 250 U/l
  • Advanced tumoral disease (vascular invasion or extrahepatic spread, portal vein thrombosis of bland or malignant origin, or diffuse HCC, defined as [50% liver involvement)
  • Contraindications for doxorubicin administration.
  • Child’s Class C
  • Vessels providing flow to the tumor that are less than 1.5 mm in diameter.
  • Subject has a known history contraindicating contrast dye or iodine that cannot be safely controlled via antihistamine, steroids, or with any other agent.
  • Unable or unwilling to provide informed consent
  • Women who are pregnant or currently breast feeding
  • Women of childbearing potential who are not using an acceptable method of birth control (e.g., pill, patch, IUD, ring, condom, sponge, foam)
  • Exclusion criteria includes portal vein thrombosis of bland or malignant origin.