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

Sirtex Medical
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.
  • 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 participant agrees to take part in this study, they 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 participant is under local anesthesia and are mildly sedated. Participant's doctor will explain this procedure to them in more detail.

If participant is one of the first 2 participants enrolled in this study, they will have their treatment over 2 sessions within 2-4 weeks, which is the standard of care. During participant's first session, an extra 10 minutes will be added to their standard imaging for research purposes. Each visit should take about 6 hours to complete. Participant 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 participant enrolls after the first 2 participants, they will have their treatment in 1 session. The visit should take about 8 hours to complete. During this visit, participant will have about 5 hours of standard of care tests and imaging. Participant 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.

Participant 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:

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

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

Length of Study:

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

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.

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:
19 January, 2017
Participants:
12
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