Yttrium-90 Radioembolization for Cirrhosis-Associated Thrombocytopenia
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|ClinicalTrials.gov Identifier: NCT03059030|
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : March 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Thrombocytopenia Cirrhosis||Device: TheraSphere® Yttrium-90 Glass Microspheres, BTG International Inc.||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Yttrium-90 Radioembolization for Cirrhosis-Associated Thrombocytopenia|
|Actual Study Start Date :||March 16, 2017|
|Estimated Primary Completion Date :||April 1, 2019|
|Estimated Study Completion Date :||April 1, 2024|
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.
- 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. [ Time Frame: 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.
- Safety of 90Y RE for the treatment of thrombocytopenia in the setting of cirrhosis. [ Time Frame: 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.
- Safety of 90Y RE for the treatment of thrombocytopenia in the setting of cirrhosis. [ Time Frame: 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.
- Asses the need for Technetium albumin aggregated (TC-MAA 99m) injection to determine shunting prior to Y90 administration [ Time Frame: 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.
- Evaluate platelet count 6 months after treatment [ Time Frame: 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
- Evaluate splenic volume post procedure [ Time Frame: 6 months ]CT or MR of the abdomen will be done at screening, 4 weeks, 3 months, and 6 months after Y90 administration
- Evaluate length of hospital stay after procedure [ Time Frame: 6 months ]Length of stay in days will be recorded post procedure
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03059030
|Contact: Carlene del Castillo, RNemail@example.com|
|Contact: Riad Salem, MD MBAfirstname.lastname@example.org|
|United States, Illinois|
|Northwestern University/Northwestern Memorial Hospital||Recruiting|
|Chicago, Illinois, United States, 60611|
|Contact: Riad Salem, MD MBA 312-695-6371 email@example.com|
|Contact: Carlene del Castillo, RN 312-695-1518 firstname.lastname@example.org|
|Principal Investigator: Riad Salem, MD MBA|
|Sub-Investigator: Robert Lewandowski, MD|
|Sub-Investigator: Daniel Ganger, MD|
|Sub-Investigator: Laura Kulik, MD|
|Sub-Investigator: Young K Chae, MD|
|Sub-Investigator: John Hayes, MD|
|Principal Investigator:||Riad Salme, MD||Northwestern University|