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Feasibility of Single Session In-Room Yttrium-90 Radioembolization Diagnostic Angiography and Treatment (NCT03028311)

Sirtex Medical
You are being asked to take part in this study because you have liver cancer or cancer that has spread to the liver are scheduled for SIR-Spheres treatment (Yttrium-90 radioembolization treatment). The goal of this clinical research study is to learn about the safety of giving SIR-Spheres treatment to patients with liver cancer in the same session rather than over 2 sessions, which is the standard of care. This is an investigational study. The SIR-Spheres is delivered using FDA approved and commercially available methods. It is investigational to learn if the procedure can be safely performed in a single session. Up to 12 participants will be enrolled in this study. All will take part at MD Anderson.
  • Device: SIR-Spheres
    SIR-Spheres - Two Sessions: Participants have SIR-Spheres treatment delivered over 2 sessions within 2-4 weeks. SIR-Spheres - One Session: Participants have SIR-Spheres treatment delivered in 1 session.
    • 90Y-radioembolization
Ages eligible for Study
18 Years and older
Genders eligible for Study
All
Accepts Healthy Volunteers
No
Inclusion Criteria:
  • Patients who are 18 years or older.
  • The ability to understand and sign informed consent.
  • Any candidate eligible for standard of care Y90 radioembolization for treatment of their primary or metastatic liver tumors.
Exclusion Criteria:
  • Patients with greater than 50% liver tumor burden.
If you agree to take part in this study, you will have standard-of-care tests and procedures as a part of the planning for SIR-Spheres treatment. The SIR-Spheres treatment delivers radiation directly to the liver by a catheter placed in an artery in the groin. A catheter is a sterile flexible tube that will be placed into a large artery while you are under local anesthesia and are mildly sedated. Your doctor will explain this procedure to you in more detail.

If you are one of the first 2 participants enrolled in this study, you will have your treatment over 2 sessions within 2-4 weeks, which is the standard of care. During your first session, an extra 10 minutes will be added to your standard imaging for research purposes. Each visit should take about 6 hours to complete. You will have about 2 hours of standard of care tests and imaging and will be asked to stay in the hospital for 1-2 hours after the procedure to recover from the anesthesia. The procedure itself should take about 2 1/2 hours to complete.

If you enroll after the first 2 participants, you will have your treatment in 1 session. The visit should take about 8 hours to complete. During this visit, you will have about 5 hours of standard of care tests and imaging. You will be asked to remain in the hospital for 1-2 hours after the procedure to recover from the anesthesia. The procedure itself should take about 2½ to 3½ hours to complete.

You will sign separate consents for the tests, procedures, and SIR-Spheres treatment that further explains the procedures and risks. The standard of care tests will include blood draws for routine testing.

Follow-Up:

You will be called by the study staff 1 month after your SIR-Spheres treatment to ask how you are doing and if you are having any side effects. The phone call should last about 10 minutes.

At about 3 months and 6 months after the treatment, you will return to the clinic for a physical exam. Blood (about 6 tablespoons) will be drawn for routine tests.

Length of Study:

You will be off study after the follow-up visits.

1 locations

United States (1)
  • University of Texas MD Anderson Cancer Center
    recruiting
    Houston, Texas, United States, 77030
Status:
recruiting
Type:
Interventional
Phase:
-
Start:
08 January, 2017
Updated:
26 November, 2017
Participants:
12
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