Yttrium-90 Radioembolization for Cirrhosis-Associated Thrombocytopenia

Evaluate the safety and efficacy of Yttrium-90 (90Y) radioembolization for the management of thrombocytopenia.

Study Overview

• Status: Recruiting
• Conditions: Thrombocytopenia; Cirrhosis
• Intervention / Treatment: Device: TheraSphere® Yttrium-90 Glass Microspheres, BTG International Inc.

Detailed Description

This protocol will provide access to TheraSphere® treatment for patients who have refractory thrombocytopenia secondary to cirrhosis. This protocol will utilize splenic artery-directed TheraSphere® treatment.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carlene del Castillo, RN; Phone Number: 312-695-1518; Email: carlene.castillo@northwestern.edu
• Study Contact Backup: Name: Riad Salem, MD MBA; Phone Number: 312-695-6371; Email: r-salem@northwestern.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern University/Northwestern Memorial Hospital
      • Contact: Carlene del Castillo, RN; Phone Number: 312-695-1518; Email: carlene.castillo@northwestern.edu
      • Contact: Riad Salem, MD MBA; Phone Number: 312-695-6371; Email: r-salem@northwestern.edu
      • Principal Investigator: Riad Salem, MD MBA
      • Sub-Investigator: Daniel Ganger, MD
      • Sub-Investigator: Laura Kulik, MD
      • Sub-Investigator: Young K Chae, MD
      • Sub-Investigator: John Hayes, MD
      • Sub-Investigator: Robert Lewandowski, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female, 18 years of age or older, of any ethnic or racial group.
• Diagnosis of cirrhosis or portal hypertension with a serum platelet count less than or equal to 80 × 109/L. [Rationale: platelet count <100 × 109/L triples the rate of liver-related adverse events (3) and worsens postoperative survival in the setting of hepatocellular carcinoma (HCC) (4). Initial platelet count of 80 × 109/L can allow the majority of patients who successfully respond to 90Y-RE (clinical endpoint of 50% platelet count increase) to exceed the 100 × 109/L threshold.]

Cirrhosis is defined by one of three criteria:

• Liver Biopsy/histology consistent with cirrhotic architectural liver changes
• Portal hypertension (Hepatic venous pressure gradient ≥10 mm Hg)
• Evidence of esophageal and/or gastric varices
• Patients must have evidence of splenomegaly as determined by screening cross-sectional imaging.
• No evidence of myelosuppression (e.g. lymphopenia) as evidenced by normal hematology values at Screening
• Adequate baseline organ function(with the exception of cirrhosis) as evidenced by normal BUN/Cr and electrolytes on screening chemistry.
• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-2
• Patient has a life expectancy of greater than 6 months without intervention.
• Patient is willing to participate in the study and has signed the study informed consent.
• Women of childbearing potential must have a negative serum pregnancy test within 28 days prior to screening and must not be breastfeeding.

Exclusion Criteria:

• Patients with serum platelet count less than 10 × 109/L.
• History of bleeding disorder attributed to another cause other than cirrhosis (e.g. Von Willebrand disease)
• Declines or unable to provide informed consent
• History of prior partial splenic embolization (PSE) or splenectomy
• Use of any medication known to increase platelet count 1 month prior to Baseline.
• History of allergy or sensitivity to TheraSphere® or its components.
• History of severe peripheral allergy or intolerance to contrast agents, narcotics, sedatives or atropine that cannot be managed medically
• Contraindications to angiography and selective visceral catheterization such as bleeding, diathesis or coagulopathy that is not correctable by usual therapy or hemostatic agents (e.g. closure device)
• Previous randomization in a trial using 90Y RE
• Patient must not have participated or enrolled in a clinical trial with an investigational device / therapy within 30 days prior to randomization
• Any serious medical condition likely to impede successful completion of the study, such as certain mental disorders, cardiac arrhythmias, and uncontrolled congestive heart failure or respiratory disease.
• Patients actively on chemotherapy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Subjects with thrombocytopenia secondary to cirrhosis; Evaluate the safety and efficacy of 90Y radioembolization for the management of thrombocytopenia.

Device: TheraSphere® Yttrium-90 Glass Microspheres, BTG International Inc.; The Interventional Radiologists will inject a dose of Yttrium 90 into your spleen through a small catheter placed in your femoral artery.The entire treatment visit is an outpatient procedure. You will only be admitted to the hospital if the physician deems it necessary due to any symptoms you may experience after the treatment is given. This visit may take 6 to 8 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of 90Y Radioembolization (RE) for the treatment of thrombocytopenia in the setting of cirrhosis, evaluated by the number of participants with treatment-related adverse events as assessed by CTCAE v4.0.	Assess for infection after Y90 treatment to the spleen by physical exam noted by a change in vital signs and lab values such as white blood count at each follow up visit.	6 months
Safety of 90Y RE for the treatment of thrombocytopenia in the setting of cirrhosis.	Assess for splenic abscess after Y90 to the spleen as seen on follow up CT imaging at 1, 3, and 6 months post treatment. This will also be evaluated at all visits by physical exam, fever, pain, and lab work. Visits occur at 2, 4, 6, 8 weeks, 3, 4, 5, 6 months.	6 months
Safety of 90Y RE for the treatment of thrombocytopenia in the setting of cirrhosis.	Assess for any adverse events after Y90 administration at follow visits or outside visits if they occur by physical exam and lab values at baseline, 2, 4, 6, 8 weeks, 3, 4, 5, 6 months post treatment. Lab value changes, ascites, fatigue, fever, nausea, dyspepsia, abdominal pain, pleural effusion, GI ulcer, pneumonitis, and thromboembolic events will be followed closely.	6 months
Asses the need for Technetium albumin aggregated (TC-MAA 99m) injection to determine shunting prior to Y90 administration	MAA injection will be done and nuclear medicine PET scan to evaluate shunting and evaluated for the first 5 patients. If shunt is <5% subsequently enrolled patients will not undergo MAA, if shunt is >5% all subsequent patients will undergo MAA. This will be evaluated post MAA injection before Y90 treatment.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate platelet count 6 months after treatment	Complete Blood Count with platelets will be drawn at baseline, treatment, 2, 4, 6, 8 weeks and 3, 4, 5, 6 months post treatment	6 months
Evaluate splenic volume post procedure	CT or MR of the abdomen will be done at screening, 4 weeks, 3 months, and 6 months after Y90 administration	6 months
Evaluate length of hospital stay after procedure	Length of stay in days will be recorded post procedure	6 months

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: BTG International Inc.
• Investigators: Principal Investigator: Riad Salme, MD, Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2017
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: February 8, 2017
• First Submitted That Met QC Criteria: February 20, 2017
• First Posted (Actual): February 23, 2017

Study Record Updates

• Last Update Posted (Estimated): November 9, 2023
• Last Update Submitted That Met QC Criteria: November 8, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: cirrhosis; Thrombocytopenia; Radioembolization; Y90; Therasphere®
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Hematologic Diseases; Liver Diseases; Blood Platelet Disorders; Fibrosis; Liver Cirrhosis; Thrombocytopenia
• Other Study ID Numbers: STU 00203772

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes