Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Patients who had received TheraSphere yttrium-90 microspheres

TheraSphere

Marnix Lam, MD, PhD

Riad Salem, MD

Etienne Garin, MD

Hugo de Jong, PhD

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.

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 consistently measure dose delivered to the tumor and normal tissue. In contrast to the standard clinical approach based on average dose to one target volume, this trial, sponsored by Biocompatibles UK, will explore an alternative two-compartment TheraSphere dosimetry methodology to calculate absorbed dose to tumor and normal tissue

A TheraSphere® Advanced Dosimetry Retrospective Global Study in HCC

A TheraSphere® Advanced Dosimetry Retrospective Global Study Evaluation in Hepatocellular Carcinoma Treatment

Normal tissue dose and tumor dose (in tumors ≥3 cm) using post-procedural yttrium-90 Positron Emission Tomography/Computed Tomography (PET/CT) imaging; collection of these endpoints will allow an assessment of the correlation with the dose determined from preprocedural 99mTc MAA SPECT or SPECT/CT imaging.

Normal tissue absorbed dose using pre-procedural 99mTc MAA (Technetium-99m Macroaggregated albumin) SPECT (Single-photon emission computer tomography) or SPECT/CT (Single-photon emission computer tomography/Computer Tomography) imaging, to allow the mean absorbed normal tissue dose corresponding to a ≤15% probability of Common Toxicities Criteria for Adverse Events (CTCAE) grade 3 or higher hyperbilirubinemia (in the absence of disease progression) to be calculated.

Tumor dose (to tumors ≥3 cm) using pre-procedural 99mTc MAA SPECT or SPECT/CT imaging.

All serious adverse events (SAEs) assessed as related or potentially related to TheraSphere

Specific non-serious adverse events (AEs) assessed as related or potentially related to the dose of TheraSphere, comprising of any of the following events:

* Hyperbilirubinemia
* Ascites
* Pain
* Fatigue
* Nausea

Objective response (OR) of the target lesion (single largest lesion) and non-target lesion(s) at 3 months and 6 months (if available), and for all scans up to 400 days after TheraSphere administration by Modified Response Evaluation Criteria in Solid Tumors (mRECIST) and Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

Volume changes (i.e., perfused liver volume and non-perfused liver volume) from baseline afterTheraSphere administration.

Target Alpha fetoprotein (AFP) response (defined as a ≥50% decrease in AFP levels for patients with a baseline AFP level of

≥200 ng/mL).

Albumin-bilirubin (ALBI) score, a measure of liver function for HCC patients after TheraSphere administration.

Dose to Portal Vein Thrombosis (PVT) based upon pre- and postprocedure imaging (if PVT present).

Dosimetric analysis time (i.e., workflow).

Dose accuracy based upon phantom imaging studies.

Measurement of inter-observer agreement based on a round robin review of the same 20 patients obtained from a minimum of 8 users (with each user at a different site) and an exploratory assessment of intra-observer agreement based on a review of 10 patients by a minimum of 8 users at least 2 weeks apart. The 10 patients for the intra-observer agreement will be a subset of the patients included in the assessment of inter-observer agreement.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A TheraSphere® Advanced Dosimetry Retrospective Global Study in HCC	NCT03295006	Hepatocellular ...	TheraSphere	18 Years -	Boston Scientific Corporation
A TheraSphere® Advanced Dosimetry Retrospective Global Study in HCC	NCT03295006	Hepatocellular ...	TheraSphere	18 Years -	Boston Scientific Corporation

Spots Global Cancer Trial Database for therasphere, hepatocellular carcinoma, dosimetry