TheraSphere & Treatment of Unresectable Primary or Unresectable Secondary Liver Cancer

NCT04090645 | Completed DMC FDA Device

• 1 other identifier: TheraSphere
• Study Type: interventional
• Target: 187
• Locations: 1 country
• Sites: 1

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

Conditions

Liver, Cancer of, Non-Resectable

Outcome Measures

Primary Outcomes (1)

• Evaluate SAE's associated with TheraSphere® treatment

  life saving measure\_ days of survival after the treament

  Day 21 after the first treatment till 24 months

Study Arms (1)

TheraShere in treatment of primary & secondary liver carcinoma

OTHER

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

Interventions

TheraSphere DEVICE

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.

TheraShere in treatment of primary & secondary liver carcinoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Methodist Health System: lead

Study Sites (1)

The Liver Institute at Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

Study Officials

• Parvez Mantry, M.D.

  Methodist Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: April 3, 2019
• First Posted: September 16, 2019
• Study Start: May 22, 2014
• Primary Completion: April 16, 2021
• Study Completion: April 16, 2021
• Last Updated: November 11, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)