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TheraSphere & Treatment of Unresectable Primary or Unresectable Secondary Liver Cancer

NCT04090645 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 187

Last updated 2021-11-11

No results posted yet for this 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

  • Liver, Cancer of, Non-Resectable

Interventions

DEVICE

TheraSphere

TheraSphere® is delivered into the liver tumor through a catheter placed into the hepatic artery. The hepatic artery provides the main blood supply to the tumor in the liver, whereas the portal vein supplies blood to normal liver parenchyma. TheraSphere® is embolized within the tumor and exerts a local beta radiation radiotherapeutic effect with a relatively limited concurrent injury to surrounding normal tissue.

Sponsors & Collaborators

  • Methodist Health System

    lead OTHER

Principal Investigators

  • Parvez Mantry, M.D. · Methodist Health System

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-22
Primary Completion
2021-04-16
Completion
2021-04-16
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04090645 on ClinicalTrials.gov