A TheraSphere® Advanced Dosimetry Retrospective Global Study in HCC (TARGET)
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|ClinicalTrials.gov Identifier: NCT03295006|
Recruitment Status : Recruiting
First Posted : September 27, 2017
Last Update Posted : April 3, 2019
|Condition or disease||Intervention/treatment|
|Hepatocellular Carcinoma||Device: TheraSphere|
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||A TheraSphere® Advanced Dosimetry Retrospective Global Study Evaluation in Hepatocellular Carcinoma Treatment|
|Actual Study Start Date :||October 31, 2016|
|Estimated Primary Completion Date :||November 30, 2019|
|Estimated Study Completion Date :||November 30, 2019|
Previous Therasphere treatment
Patients who had received TheraSphere yttrium-90 microspheres
Patients who had received TheraSphere
- Alternative two-compartment TheraSphere dosimetry methodology [ Time Frame: Baseline ]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 [ Time Frame: Baseline ]Tumor dose (to tumors ≥3 cm) using pre-procedural 99mTc MAA SPECT or SPECT/CT imaging.
- Serious adverse events [ Time Frame: 3 months ]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 [ Time Frame: 3 months ]
Specific non-serious adverse events (AEs) assessed as related or potentially related to the dose of TheraSphere, comprising of any of the following events:
- Clinical laboratory assessments [ Time Frame: 6 weeks and 3 months ]Clinical laboratory assessments
- Objective response (OR) of the target lesion and non-target sesions [ Time Frame: 3 months and 6 months ]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 [ Time Frame: 3 and 6 months ]Volume changes (i.e., perfused liver volume and non-perfused liver volume) from baseline afterTheraSphere administration.
- Overall Survival (OS) [ Time Frame: 6 months ]Overall Survival (OS)
- Target Alpha fetoprotein (AFP) response [ Time Frame: 6 weeks and 3 months ]
Target Alpha fetoprotein (AFP) response (defined as a ≥50% decrease in AFP levels for patients with a baseline AFP level of
- Albumin-bilirubin (ALBI) score [ Time Frame: 6 weeks and 3 months ]Albumin-bilirubin (ALBI) score, a measure of liver function for HCC patients after TheraSphere administration.
- Dose to Portal Vein Thrombosis (PVT) [ Time Frame: baseline, 90 days, 180 days ]Dose to Portal Vein Thrombosis (PVT) based upon pre- and postprocedure imaging (if PVT present).
- Dosimetric analysis time [ Time Frame: baseline ]Dosimetric analysis time (i.e., workflow).
- Dose accuracy [ Time Frame: baseline ]Dose accuracy based upon phantom imaging studies.
- Dose reproducibility [ Time Frame: baseline ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03295006
|Contact: Frances Harrisonemail@example.com|
|Principal Investigator:||Marnix Lam, MD, PhD||Universitair Medisch Centrum Utrecht|
|Principal Investigator:||Riad Salem, MD||Northwestern University|
|Principal Investigator:||Etienne Garin, MD||Centre Eugène Marquis|
|Principal Investigator:||Hugo de Jong, PhD||Universitair Medisch Centrum Utrecht|