Status:
COMPLETED
A TheraSphere® Advanced Dosimetry Retrospective Global Study in HCC
Lead Sponsor:
Boston Scientific Corporation
Collaborating Sponsors:
Biocompatibles UK Ltd
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Brief Summary
This retrospective, multinational, single-arm study will be conducted in at least 8 sites. An interim analysis will be conducted with data from 100 patients with up to 10 well defined HCC tumor(s) and...
Detailed Description
Recently published evidence indicates a correlation between yttrium-90 dose delivered to the tumor and normal tissue with safety and efficacy outcomes but there are no validated methods to consistentl...
Eligibility Criteria
Inclusion
- Up to 10 well defined unilobar/bilobar HCC tumor(s) per lobe with at least one tumor ≥3 cm ± PVT
- Liver dominant disease (limited extra-hepatic metastases in the lung and/or lymph nodes are permitted (up to 5 lesions in the lung, with each individual lesion ≤2cm; any number of lymph node lesions with each individual lesion ≤2 cm).
- Child Pugh stage A or B7.
- BCLC A, B or C.
- Must be male or female, 18 years of age or older.
- Bilirubin ≤2 mg/dL.
- Tumor replacement \<50% of total liver volume assessed by diagnostic imaging consisting of multi-phase contrast enhanced CT or contrast enhanced MRI.
- Diagnostic imaging consisting of multi-phase contrast enhanced CT or contrast enhanced MRI within 3 months prior to TheraSphere® administration.
- Infusion of 99mTc-MAA in a single arterial location sufficient to cover up to 10 well-defined tumors per lobe ≤ 6 weeks prior to TheraSphere® administration.
- Patients must have received TheraSphere® in a single treatment setting in one or more arterial locations sufficient to cover up to 10 well-defined tumors based on angiography. Subsequent TheraSphere® treatment to the second lobe may occur at least 4 weeks following the initial TheraSphere® treatment.
- For patients receiving a second TheraSphere® treatment bilirubin levels must have been recorded prior to the second treatment
- Patients must have had clinical evaluation (assessment of liver specific AEs) and laboratory evaluation (at least a serum bilirubin level) at baseline.
- Tumor(s), ≥3 cm, measurable by mRECIST and RECIST 1.1 at baseline
Exclusion
- Prior external beam radiation treatment to the liver.
- Prior loco-regional liver directed therapy (cTACE, DEB-TACE and SIR-Spheres).
- Prior liver transplantation.
- Whole liver TheraSphere® treatment following prior liver resection.
- TheraSphere administration to ≤2 segments (e.g., radiation segmentectomy).
- Additional active therapy (TACE and treatment with SIR-Spheres) between first TheraSphere treatment and 3 month (90 days) imaging.
- Hepatic vein invasion.
- Diagnosis of disease progression at peri-procedural imaging as compared to the baseline imaging (physician's discretion).
Key Trial Info
Start Date :
October 31 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
209 Patients enrolled
Trial Details
Trial ID
NCT03295006
Start Date
October 31 2016
End Date
December 1 2020
Last Update
April 21 2021
Active Locations (14)
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1
Stanford University Medical Center
Stanford, California, United States, 94305-5642
2
University of Florida College of Medicine
Gainesville, Florida, United States, 32610-0374
3
Northwestern Memorial Hospital, Robert H Lurie Comprehensive Cancer Center
Chicago, Illinois, United States, 60611-2927
4
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202