Yttrium-90 Radioembolization for Cirrhosis-Associated Thr... | NCT03059030

NCT03059030

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
BTG International Inc.	OTHER

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.

Secondary Outcomes

Measure	Description	Time Frame
Achieve a 50% Increase in Platelet Count Six Months After Therapy.	Complete Blood Count with platelets will be drawn at baseline, treatment, 2, 4, 6, 8 weeks and 3, 4, 5, 6 months post treatment. Comparison made with screening platelet count and 6 month follow up visit platelet count.	6 months
Achieve 20% Decrease in Functional Splenic Volume Six Months After Treatment

Eligibility Module

Eligibility Criteria

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.

Name	Affiliation	Role
Riad Salem, MD	Northwestern University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Northwestern University/Northwestern Memorial Hospital		Chicago	Illinois	60611	United States

ID	Title	Description
FG000	Subjects With Thrombocytopenia Secondary to Cirrhosis	Evaluate the safety and efficacy of 90Y radioembolization for the management of thrombocytopenia. 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.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Subjects With Thrombocytopenia Secondary to Cirrhosis	Evaluate the safety and efficacy of 90Y radioembolization for the management of thrombocytopenia. 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.

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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

All subjects enrolled received treatment per protocol.

Posted

Number

events

6 months

ID	Title	Description
OG000	Subjects With Thrombocytopenia Secondary to Cirrhosis

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Subjects With Thrombocytopenia Secondary to Cirrhosis	Evaluate the safety and efficacy of 90Y radioembolization for the management of thrombocytopenia. 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. There was only one arm of this study and all subjects were treated. No subjects had severe adverse events and none died during the duration of the study. All adverse events reported at follow up visits were reported.

ID	Term
D001791	Blood Platelet Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D000095542	Cytopenia

ID	Term
D013921	Thrombocytopenia
D005355	Fibrosis