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NCT04090645 · ClinicalTrials.gov registry record · NA
TheraSphere & Treatment of Unresectable Primary or Unresectable Secondary Liver Cancer
A NA study of Liver, Cancer of, Non-Resectable, sponsored by Methodist Health System.
- Completed
- Registry status
- NA
- Development phase
- 187
- Enrollment target
- 1
- Study location
NCT04090645 is a NA study of Liver, Cancer of, Non-Resectable that has completed, run by Methodist Health System. The registered enrollment target is 187 participants. The trial reports 1 study location across 1 state.
The verdict
NCT04090645, a NA study of Liver, Cancer of, Non-Resectable, has completed, sponsored by Methodist Health System.
- COMPLETED
- Registry status
- NA
- Development phase
- 187 participants
- Enrollment target
- 1
- Study location
Study Summary
Protocol Synopsis Title A Humanitarian Device Exemption Use Protocol of TheraSphere® For Treatment of Unresectable Primary or Secondary Liver Neoplasia Supplier BTG International Canada Inc. Type of Clinical Use Post-Marketing: TheraSphere® commercially distributed under HDE # 980006 Objectives • Provide supervised access to TheraSphere® therapy at this institution * Evaluate response to treatment * Evaluate toxicities and adverse experiences associated with TheraSphere® treatment * Evaluate survival time Number of Patients Up to 100 patients per year, expandable following completion of the first cohort. Patients will be excluded: if they have pre-existing diarrhea/illness, or if they have a co-morbid disease or condition that would preclude safe delivery of TheraSphere® treatment and place the patient at undue risk. Required Lab Parameters AST or ALT \<5 times ULN For HCC: Bilirubin ≤ 2.0 mg/dl (unless segmental infusion is used) Negative pregnancy test in premenopausal women For other primary or secondary liver neoplasia, bilirubin levels specific to the primary or secondary liver neoplasia will be determined to confirm suitability for TheraSphere® treatment Negative pregnancy test in premenopausal women Endpoints Provide TheraSphere® for patients who it is determined by their treating physicians and/or tumor board that the device is appropriate for the treatment of unresectable HCC in accordance with the FDA recommendation of use of a HUD within its approved indication or for the treatment of the patient's other primary or secondary liver neoplasia and is in accordance with the FDA recommendation of use of a HUD outside of its approved indication. Evaluate SAE's associated with TheraSphere® treatment. TheraSphere® Treatment: Suggested Table of Time and Events. TIME Pre-Treatment Evaluation First Treatment First Follow-up Visit Second Treatment3 Post-Treatment Follow-up3 EVENTS -30 to -5 Days Day 0 Day 21 - 42 Day 30 - 90 3 months * 24 months
Conditions Studied
Interventions
- DEVICE TheraSphere
Study Locations (1)
Texas
- The Liver Institute at Methodist Dallas Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 187 participants |
| Start Date | 2014-05-22 |
| Est. Completion | 2021-04-16 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04090645
The ClinicalTrials.gov registry entry for NCT04090645 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 187 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Methodist Health System, which has 125 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Liver, Cancer of, Non-Resectable appearing as the primary indexed condition, and to 1 intervention - of which TheraSphere is the first listed.
NCT04090645 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT04090645 about?
NCT04090645 is a clinical study titled "TheraSphere & Treatment of Unresectable Primary or Unresectable Secondary Liver Cancer". Protocol Synopsis Title A Humanitarian Device Exemption Use Protocol of TheraSphere® For Treatment of Unresectable Primary or Secondary Liver Neoplasia Supplier BTG International Canada Inc. Type of Clinical Use Post-Marketing: TheraSphere® commercially distributed under HDE # 980006 Objectives •...
What is the current status of trial NCT04090645?
This trial is currently completed. It is a NA study. The enrollment target is 187 participants. The study started on 2014-05-22. Estimated completion is 2021-04-16.
What conditions does trial NCT04090645 study?
This clinical trial studies the following conditions: Liver, Cancer of, Non-Resectable.
What interventions are being tested in trial NCT04090645?
The interventions under investigation include: TheraSphere (DEVICE).
Who is sponsoring clinical trial NCT04090645?
This trial is sponsored by Methodist Health System, which has 125 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04090645 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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