Yttrium-90 Radioembolization for Cirrhosis-Associated Thrombocytopenia

Sponsor
Northwestern University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03059030
Collaborator
BTG International Inc. (Other)
20
1
1
96.5
0.2

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: TheraSphere® Yttrium-90 Glass Microspheres, BTG International Inc.
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Yttrium-90 Radioembolization for Cirrhosis-Associated Thrombocytopenia
Actual Study Start Date :
Mar 16, 2017
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Apr 1, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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. [6 months]

    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.

  2. Safety of 90Y RE for the treatment of thrombocytopenia in the setting of cirrhosis. [6 months]

    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.

  3. Safety of 90Y RE for the treatment of thrombocytopenia in the setting of cirrhosis. [6 months]

    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.

  4. Asses the need for Technetium albumin aggregated (TC-MAA 99m) injection to determine shunting prior to Y90 administration [6 months]

    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.

Secondary Outcome Measures

  1. Evaluate platelet count 6 months after treatment [6 months]

    Complete Blood Count with platelets will be drawn at baseline, treatment, 2, 4, 6, 8 weeks and 3, 4, 5, 6 months post treatment

  2. Evaluate splenic volume post procedure [6 months]

    CT or MR of the abdomen will be done at screening, 4 weeks, 3 months, and 6 months after Y90 administration

  3. Evaluate length of hospital stay after procedure [6 months]

    Length of stay in days will be recorded post procedure

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Northwestern University/Northwestern Memorial Hospital Chicago Illinois United States 60611

Sponsors and Collaborators

  • Northwestern University
  • BTG International Inc.

Investigators

  • Principal Investigator: Riad Salme, MD, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Riad Salem, Chief, Vascular and Interventional Radiology, Northwestern University
ClinicalTrials.gov Identifier:
NCT03059030
Other Study ID Numbers:
  • STU 00203772
First Posted:
Feb 23, 2017
Last Update Posted:
Mar 9, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by Riad Salem, Chief, Vascular and Interventional Radiology, Northwestern University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 9, 2022