Actively Recruiting
Optimizing Y90 Therapy for Radiation Lobectomy
Led by Northwestern University · Updated on 2026-03-27
104
Participants Needed
2
Research Sites
310 weeks
Total Duration
On this page
Sponsors
N
Northwestern University
Lead Sponsor
M
Mayo Clinic
Collaborating Sponsor
AI-Summary
What this Trial Is About
HCC resection candidates with inadequate future liver remnant will be enrolled in this study. They will be treated with Y90 radioembolization to help grow the liver enough to undergo liver resection. There will be 2 Patient Groups. The first group of patients will be treated with Y90 dose and embolic load as per standard-of-care. The second group of patients will be treated with the optimal Y90 dose and embolic load found in Patient Group 1.
CONDITIONS
Official Title
Optimizing Y90 Therapy for Radiation Lobectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with hepatocellular carcinoma confirmed by histology or meeting AASLD imaging criteria
- Child-Pugh stage A liver function
- Future Liver Remnant (FLR) less than 40%
- ECOG Performance Status of 0 or 1
- Bilirubin level of 3.0 mg/dl or less (treatment may proceed with higher bilirubin if tumor is vascularly isolated)
- Creatinine level of 2.0 mg/dl or less
- Absolute neutrophil count (ANC) of 1.5 K/uL or higher
- Platelet count greater than 25 K/uL
- Willingness to participate and signed consent
- For Group 2 only: planned Y90 dose and embolic load within optimal range found in Group 1
You will not qualify if you...
- Pregnant women or women of childbearing potential who have not undergone hysterectomy or bilateral oophorectomy and have had menses in the past 12 months
- For Group 2 only: contraindications to MRI including severe claustrophobia, allergy to gadolinium contrast, presence of pacemaker or metal implants, or low kidney function (eGFR less than 30 mL/min/m2)
- Significant life-threatening extra-hepatic disease or secondary malignancies
- Patients on dialysis or with unresolved diarrhea or serious infections including HIV, acute HBV or HCV
- Contraindications to angiography or catheterization such as uncorrectable bleeding disorders
- Co-morbid conditions that pose undue risk for TheraSphere treatment
- History of severe allergy or intolerance to contrast agents, narcotics, sedatives, or atropine that cannot be medically managed
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Mayo Clinic
Jacksonville, Florida, United States, 32224
Active, Not Recruiting
2
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
Research Team
R
Robert Lewandowski, MD
CONTACT
K
Kristie Kennedy, MA
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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