Yttrium-90 Radioembolization for Cirrhosis-Associated Thrombocytopenia

NCT03059030 | Terminated Results DMC FDA Device

• 1 other identifier: STU 00203772
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Thrombocytopenia; Cirrhosis

Keywords

Thrombocytopenia; cirrhosis; Therasphere®; Y90; Radioembolization

Outcome Measures

Primary Outcomes (4)

• The Primary Objective of This Pilot Study is to Evaluate the Safety of 90Y TARE for the Treatment of Thrombocytopenia in the Setting of Cirrhosis. Evaluation of Overall AE Reporting in All Categories.

  The number and the severity of ALL adverse events will be recorded to evaluate safety. Events will be reported by subjects at follow up visits. Scale: Common Terminology Criteria for Adverse Events (CTCAE) CT CAE v 4.0.3 Grades range from 1-5 with 5 being the worst (Death), descriptions of each grade for specific AE's are available here: https://evs.nci.nih.gov/ftp1/CTCAE/CTCAE\_4.03/CTCAE\_4.03\_2010-06-14\_QuickReference\_8.5x11.pdf Total AE's of different types are collected and for each grade are reported as a group

  6 months

• Safety of 90Y RE for the Treatment of Thrombocytopenia in the Setting of Cirrhosis. Reporting of Splenic Abscess.

  The number and the severity of adverse events related to splenic abscess will be recorded to evaluate safety. Events will be reported by subjects at follow up visits. Scale: Common Terminology Criteria for Adverse Events (CTCAE) CT CAE v 4.0.3 Grades range from 1-5 with 5 being the worst (Death), Grade 1 (Mild):Small abscess with minimal symptoms, often not requiring intervention. Grade 2 (Moderate):Larger abscess causing moderate symptoms, may require antibiotics or drainage procedures. Grade 3 (Severe):Large abscess with significant symptoms, potentially causing systemic effects, requiring hospitalization and aggressive management. Grade 4 (Life-threatening):Abscess with immediate life-threatening complications, requiring urgent intervention. Grade 5 Death

  6 months

• Safety of 90Y RE for the Treatment of Thrombocytopenia in the Setting of Cirrhosis. AE's Related to Infection.

  The number and the severity of adverse events related to infection will be recorded to evaluate safety. Events will be reported by subjects at follow up visits. Common Terminology Criteria for Adverse Events (CTCAE) CT CAE v 4.0.3, Grades range from 1-5 with 5 being the worst (Death) Grade 1 (Mild): Asymptomatic or mild symptoms, only requiring clinical observation, no intervention needed. Grade 2 (Moderate): Symptoms limiting some daily activities, minimal intervention may be required. Grade 3 (Severe): Symptoms significantly impacting self-care, requiring hospitalization or prolonged stay. Grade 4 (Life-threatening): Urgent intervention needed due to life-threatening complications. Grade 5 (Death): Death directly related to the infection.

  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 4 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 Outcomes (3)

• Achieve a 50% Increase in Platelet Count Six Months After Therapy.

  6 months

• Achieve 20% Decrease in Functional Splenic Volume Six Months After Treatment

  6 months

• Evaluate Length of Hospital Stay After Procedure

  6 months

Study Arms (1)

Subjects with thrombocytopenia secondary to cirrhosis

EXPERIMENTAL

Evaluate the safety and efficacy of 90Y radioembolization for the management of thrombocytopenia.

Device: TheraSphere® Yttrium-90 Glass Microspheres, BTG International Inc.

Interventions

TheraSphere® Yttrium-90 Glass Microspheres, BTG International Inc. DEVICE

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.

Subjects with thrombocytopenia secondary to cirrhosis

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead
• BTG International Inc.: collaborator

Study Sites (1)

Northwestern University/Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Thrombocytopenia; Fibrosis

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results. There were too few eligible candidates or willing participants over several years even with several clinics and a multidisciplinary team reviewing potential candidates. The trial was terminated for low enrollment.

Results Point of Contact

• Title: Riad Salem MD
• Organization: Northwestern University

rsalem1@nm.org

312-695-6371

Study Officials

• Riad Salem, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Vascular and Interventional Radiology

Study Record Dates

• First Submitted: February 8, 2017
• First Posted: February 23, 2017
• Study Start: March 16, 2017
• Primary Completion: April 4, 2024
• Study Completion: April 4, 2024
• Last Updated: February 3, 2025
• Results First Posted: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)