Trial Search Results

A TheraSphere® Advanced Dosimetry Retrospective Global Study in HCC

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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

BTG International Inc.

Stanford Investigator(s):

Intervention(s):

  • Device: TheraSphere

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).

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Recruiting