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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 is a clinical trial that has completed, run by Boston Scientific Corporation. The registered enrollment target is 209 participants.
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.
Interventions
- DEVICE TheraSphere
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 209 participants |
| Start Date | 2016-10-31 |
| Est. Completion | 2020-12-01 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03295006
The ClinicalTrials.gov registry entry for NCT03295006 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 209 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Scientific Corporation, which has 280 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which TheraSphere is the first listed.
NCT03295006 reports 0 study locations.
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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