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A TheraSphere® Advanced Dosimetry Retrospective Global Study in HCC
Recruiting
Trial ID: NCT03295006
Purpose
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 with at least one tumor ≥3 cm. Normal tissue absorbed dose using pre-procedural
99mTc MAA SPECT or SPECT/CT imaging will be measured to allow the mean absorbed normal tissue
dose corresponding to a ≤15% probability of CTCAE grade 3 or higher hyperbilirubinemia (in
the absence of disease progression) to be calculated. Total bilirubin will be recorded and
graded according to CTCAE version 4.02. All dose-related SAEs at 3 months follow-up will be
followed until resolution, death or lost-to-follow-up. AEs related to disease progression
will not be considered related to TheraSphere.
Official Title
A TheraSphere® Advanced Dosimetry Retrospective Global Study Evaluation in Hepatocellular Carcinoma Treatment
Stanford Investigator(s)
Daniel Sze, MD, PhD
Professor of Radiology (Interventional Radiology)
David S. Wang, MD
Clinical Associate Professor, Radiology
Eligibility
Inclusion Criteria:
- 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 Criteria:
- 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).
Intervention(s):
device: TheraSphere
Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305