Trial Title:
Radioembolization Trial Utilizing Eye90 Microspheres™ for the Treatment of Hepatocellular Carcinoma (HCC)
NCT ID:
NCT05953337
Condition:
Hepatocellular Carcinoma
Hepatocellular Carcinoma Non-resectable
Liver Cancer
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Liver Neoplasms
Conditions: Keywords:
Hepatocellular Carcinoma
Liver Cancer
Liver Diseases
Internal radiation brachytherapy
Radioembolization
Y90
Yttrium-90
Eye90 microspheres
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
EYE90 Microspheres Treatment
Description:
Y90 glass microspheres
Arm group label:
EYE90 Microspheres Treatment
Summary:
This is a prospective, multi-center, open-label study to evaluate the effectiveness and
safety of Eye90 microspheres® in the treatment of subjects with unresectable
Hepatocellular Carcinoma (HCC). Eye90 microspheres is a medical device containing
yttrium-90 (Y-90), a radioactive material, and provides local radiation brachytherapy for
the treatment of liver tumors.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Must have a confirmed diagnosis of HCC by imaging confirmation with Liver Imaging
Reporting and Data System (LIRADS) category 5 or confirmation of HCC via biopsy.
- No extra hepatic disease.
- Up to 3 lesions with at least one lesion ≥ 2 cm in diameter (long axis) measurable
by computed tomography (CT), CBCT, or MRI. At least one lesion must be identified as
a target lesion as defined by mRECIST.
- Maximal single lesion size of ≤ 8 cm and sum of the maximal tumor dimensions of ≤ 12
cm with the entire tumor burden expected to be treatable within the perfused volume.
- Intent to treat all lesions within a single session.
- Hypervascular on CBCT, CT, or MRI.
- Evidence that > 33% of the total liver volume is disease-free and will be spared
Eye90 treatment.
- Life expectancy of ≥ 6 months.
- ≥ 18 years old at the time of informed consent
Exclusion Criteria:
- Platelet count <50,000/microliter or prothrombin (PT) activity > 50% normal.
- Hemoglobin ≤ 8.5 g/dL (subjects that are non-responders to transfusion or medical
management must be excluded).
- INR > 1.7 (if anticoagulated, reversal must be achieved prior to any angiographic
procedures).
- ALT > 5x upper limit.
- AST > 5x upper limit.
- Bilirubin ≥ 2.0 mg/dL.
- eGFR ≤ 50 mL/min/BSA.
- Macrovascular invasion.
- Incompetent biliary duct system, prior biliary intervention, or a compromised
Ampulla of Vater.
- Estimated lung dose > 30 Gy as calculated using the lung shunt fraction and
partition model.
Gender:
All
Minimum age:
18 Years
Maximum age:
99 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The University of Arizona Cancer Center
Address:
City:
Tucson
Zip:
85719
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Investigator:
Last name:
Shamar Young, MD
Email:
Principal Investigator
Facility:
Name:
University of California - Irvine
Address:
City:
Orange
Zip:
92867
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Investigator:
Last name:
Nadine Abi-Jaoudeh, MD
Email:
Principal Investigator
Facility:
Name:
AdventHealth Radiation Oncology at Altamonte Springs
Address:
City:
Altamonte Springs
Zip:
32701
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Investigator:
Last name:
Ravi Shridhar, MD
Email:
Principal Investigator
Facility:
Name:
Piedmont Hospital
Address:
City:
Atlanta
Zip:
30309
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Investigator:
Last name:
Rahul Maheshwari, MD
Email:
Principal Investigator
Facility:
Name:
University of Louisville
Address:
City:
Louisville
Zip:
40202
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Investigator:
Last name:
Robert Martin, MD
Email:
Principal Investigator
Facility:
Name:
Ochsner Clinic Foundation
Address:
City:
New Orleans
Zip:
70121
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator, MD
Investigator:
Last name:
Juan Gimenez, MD
Email:
Principal Investigator
Facility:
Name:
Beth Israel Deaconess
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Investigator:
Last name:
Ammar Sarwar, MD
Email:
Principal Investigator
Facility:
Name:
University of Missouri - Ellis Fischel Cancer Center
Address:
City:
Columbia
Zip:
65212
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Investigator:
Last name:
Ryan Davis, MD
Email:
Principal Investigator
Facility:
Name:
SSM Health Saint Louis University
Address:
City:
Saint Louis
Zip:
63104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Investigator:
Last name:
Kirubahara Vaheesan, MD
Email:
Principal Investigator
Facility:
Name:
Weill Cornell Medicine-New York Presbyterian Hospital
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Investigator:
Last name:
Adam Talenfeld, MD
Email:
Principal Investigator
Facility:
Name:
Charlotte Radiology
Address:
City:
Charlotte
Zip:
28202
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Investigator:
Last name:
Eric Wang, MD
Email:
Principal Investigator
Facility:
Name:
Hospital of the University of Pennsylvania
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Investigator:
Last name:
Gregory Nadolski, MD
Email:
Principal Investigator
Facility:
Name:
HCA Healthcare Research Institute (Sarah Cannon)
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Investigator:
Last name:
Andrew Kennedy, MD
Email:
Principal Investigator
Facility:
Name:
University of Utah
Address:
City:
Salt Lake City
Zip:
84112
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Investigator:
Last name:
Ziga Cizman, MD
Email:
Principal Investigator
Facility:
Name:
Inland Imaging
Address:
City:
Spokane
Zip:
99203
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Investigator:
Last name:
Jayson Brower, MD
Email:
Principal Investigator
Facility:
Name:
Froedtert Hospital/Medical College of Wisconsin
Address:
City:
Milwaukee
Zip:
53226
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Investigator:
Last name:
William Rilling, MD
Email:
Principal Investigator
Start date:
September 21, 2023
Completion date:
October 2025
Lead sponsor:
Agency:
ABK Biomedical
Agency class:
Industry
Source:
ABK Biomedical
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05953337
