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NCT03295006 · ClinicalTrials.gov registry record
A TheraSphere® Advanced Dosimetry Retrospective Global Study in HCC
A clinical trial, sponsored by Boston Scientific Corporation.
- Completed
- Registry status
- 209
- Enrollment target
NCT03295006: Completed study, sponsored by Boston Scientific Corporation.
NCT03295006 is a clinical trial that has completed, run by Boston Scientific Corporation. The registered enrollment target is 209 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03295006 has completed, sponsored by Boston Scientific Corporation.
- COMPLETED
- Registry status
- 209 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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.
Interventions
- DEVICE TheraSphere
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 209 participants |
| Start Date | 2016-10-31 |
| Est. Completion | 2020-12-01 |
What the finished NCT03295006 record still lists
NCT03295006 is an observational study that tracks outcomes without assigning an intervention. The registered 209 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which TheraSphere is the first listed.
NCT03295006 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03295006 about?
NCT03295006 is a clinical study titled "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 ...
What is the current status of trial NCT03295006?
This trial is currently completed. The enrollment target is 209 participants. The study started on 2016-10-31. Estimated completion is 2020-12-01.
What interventions are being tested in trial NCT03295006?
The interventions under investigation include: TheraSphere (DEVICE).
Who is sponsoring clinical trial NCT03295006?
This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.
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