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TheraSphere & Treatment of Unresectable Primary or Unresectable Secondary Liver Cancer

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ClinicalTrials.gov Identifier: NCT04090645
Recruitment Status : Recruiting
First Posted : September 16, 2019
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
Methodist Health System

Brief 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

Condition or disease Intervention/treatment Phase
Liver, Cancer of, Non-Resectable Device: TheraSphere Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Intervention Model: Single Group Assignment
Intervention Model Description: TheraSphere® consists of insoluble glass microspheres where Y-90 is an integral constituent of the glass. The mean sphere diameter ranges from 20 to 30 µm. Each milligram contains between 22,000 and 73,000 microspheres. TheraSphere® is supplied in 0.6 mL of sterile, pyrogen-free water contained in a 1.0 mL vee-bottom vial secured within a 12 mm clear acrylic vial shield. TheraSphere® is available in six activity sizes: 3 GBq (81 mCi), 5 GBq (135 mCi), 7 GBq (189 mCi), 10 GBq (270 mCi), 15 GBq (405 mCi) and 20 GBq (540 mCi).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Humanitarian Device Exemption Treatment Protocol of TheraSphere for Treatment of Unresectable Primary or Unresectable Secondary Liver Cancer
Actual Study Start Date : May 22, 2014
Estimated Primary Completion Date : May 2025
Estimated Study Completion Date : May 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

Arm Intervention/treatment
TheraShere in treatment of primary & secondary liver carcinoma
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.
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.




Primary Outcome Measures :
  1. Evaluate SAE's associated with TheraSphere® treatment [ Time Frame: Day 21 after the first treatment till 24 months ]
    life saving measure_ days of survival after the treament



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients over 18 years of age, of any race or sex, who have hepatocellular carcinoma of the liver, and who are able to give informed consent, will be eligible. Patients must have an ECOG Performance Status score of ≤ 2, with a life expectancy of ≥ 3 months, non-pregnant with an acceptable contraception in premenopausal women. Patients must be >4 weeks since prior radiation or prior surgery and at least 1 month post chemotherapy.

Exclusion Criteria:

  • Contraindications to angiography and selective visceral catheterization

    • Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) per treatment of radiation to the lungs
    • Evidence of any detectable Tc-99m MAA flow to the stomach or duodenum, after application of established angiographic techniques to stop or mitigate such flow (eg, placing catheter distal to gastric vessels)
    • Significant extrahepatic disease representing an imminent life-threatening outcome
    • Severe liver dysfunction or pulmonary insufficiency
    • Active uncontrolled infection
    • Significant underlying medical or psychiatric illness
    • Pregnancy

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04090645


Contacts
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Contact: Crystee Cooper, DHEd 214-947-1280 CrysteeCooper@mhd.com
Contact: Nitasha Phatak, Ph.D. 214-947-4459 NitashaPhatak@mhd.com

Locations
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United States, Texas
The Liver Institute at Methodist Dallas Medical Center Recruiting
Dallas, Texas, United States, 75203
Principal Investigator: Parvez Mantry, MD         
Sponsors and Collaborators
Methodist Health System
Investigators
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Principal Investigator: Parvez Mantry, M.D. Methodist Health System

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Responsible Party: Methodist Health System
ClinicalTrials.gov Identifier: NCT04090645     History of Changes
Other Study ID Numbers: TheraSphere
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Liver Extracts
Hematinics