Clinical trial NCT03059030: Yttrium-90 Radioembolization for Cirrhosis-Associated Thrombocytopenia
Official title: Yttrium-90 Radioembolization for Cirrhosis-Associated Thrombocytopenia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Thrombocytopenia
Cirrhosis
Keywords: Thrombocytopenia
cirrhosis
Therasphere®
Y90
Radioembolization
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: BTG International Inc.
First posted: 2017-02-23
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

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.

Primary outcomes:
measure: 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.
timeFrame: 6 months
measure: Safety of 90Y RE for the Treatment of Thrombocytopenia in the Setting of Cirrhosis. Reporting of Splenic Abscess.
timeFrame: 6 months
measure: Safety of 90Y RE for the Treatment of Thrombocytopenia in the Setting of Cirrhosis. AE's Related to Infection.
timeFrame: 6 months
measure: Asses the Need for Technetium Albumin Aggregated (TC-MAA 99m) Injection to Determine Shunting Prior to Y90 Administration
timeFrame: 6 months
Secondary outcomes:
measure: Achieve a 50% Increase in Platelet Count Six Months After Therapy.
timeFrame: 6 months
measure: Achieve 20% Decrease in Functional Splenic Volume Six Months After Treatment
timeFrame: 6 months
measure: Evaluate Length of Hospital Stay After Procedure
timeFrame: 6 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University/Northwestern Memorial Hospital
state: Illinois
Study officials:
affiliation: Northwestern University
name: Riad Salem, MD
role: PRINCIPAL_INVESTIGATOR
References: