Feasibility of Single Session In-Room Yttrium-90 Radioembolization Diagnostic Angiography and Treatment
| Status: | Recruiting |
|---|---|
| Conditions: | Liver Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/8/2018 |
| Start Date: | January 9, 2017 |
| End Date: | January 1, 2021 |
| Contact: | Armeen Mahvash, MD |
| Phone: | 713-563-7340 |
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.
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.
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.
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.
Inclusion Criteria:
1. Patients who are 18 years or older.
2. The ability to understand and sign informed consent.
3. Any candidate eligible for standard of care Y90 radioembolization for treatment of
their primary or metastatic liver tumors.
Exclusion Criteria:
1) Patients with greater than 50% liver tumor burden.
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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