A TheraSphere® Advanced Dosimetry Retrospective Global Study in HCC

Completed

Conditions studied: Hepatocellular Carcinoma

In brief

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.

Key facts

Study ID

NCT03295006

Run by

Boston Scientific Corporation

People needed

209

Starts

2016-10-31

Expected to finish

2020-12-01

Last updated by the study team

2021-04-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).

Where it is running

• Stanford University Medical Center — Stanford, California, United States
• University of Florida College of Medicine — Gainesville, Florida, United States
• Northwestern Memorial Hospital, Robert H Lurie Comprehensive Cancer Center — Chicago, Illinois, United States
• Indiana University School of Medicine — Indianapolis, Indiana, United States
• Washington University in St. Louis, School of Medicine — Saint Louis, Louisiana, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• Centre Eugene Marquis — Rennes, France
• Universitätsklinikum Essen — Essen, Germany
• Foundation IRCCS Istituto Nazionale Tumori — Milan, Italy
• Universitair Medisch Centrum Utrecht — Utrecht, Netherlands
• King Faisal Hospital — Riyāḑ, Saudi Arabia
• Centre Hospitalier Universitaire Vaudois — Lausanne, Switzerland
• Istanbul university Istanbul medical school — Fatih, Turkey (Türkiye)
• Florence Nightingale — Şişli, Turkey (Türkiye)

Full record on ClinicalTrials.gov

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