Yttrium Y-90 Radioembolization in Treating Patients With Metastatic Liver Cancer

Stage IV Liver Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03028311
• Other study ID #: 2016-0244
• Secondary ID: NCI-2017-0062920
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: January 9, 2017
• Est. completion date: January 31, 2025

Study information

• Verified date: March 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This clinical trial studies the side effects and best way to perform yttrium Y-90 radioembolization in treating patients with liver cancer that has spread to other places in the body (metastatic). Yttrium Y-90 radioembolization is a therapy that injects radioactive microspheres directly into an artery that feeds liver tumors to cut off their blood supply. Performing yttrium Y-90 radioembolization in a single session may make treatment faster, minimize patient travel, and decrease the overall cost of the procedure.

Description:

PRIMARY OBJECTIVE: I. To evaluate the feasibility and safety of same day yttrium-90 radioembolization planning and treatment angiography. SECONDARY OBJECTIVES: I. To determine the patient costs associated with same diagnostic and treatment compared when compared to the standard two session methodology. II. To determine the time required to perform the mandatory in-room technetium Tc-99m albumin aggregated (99mTc-MAA) imaging and the associated calculations for the lung shunt fraction and treatment 90Y-microsphere activity. III. To determine the time for delivery of the therapy 90Y-microsphere radioactivity to the angiography suite after the therapy written directive by the authorized user. OUTLINE: The first 2 patients enrolled receive standard of care diagnostic and treatment during 2 visits for approximately 6 hours each within 2-4 weeks. During the first visit, patients undergo diagnostic angiography with embolization of potential hepatoenteric collaterals, receive technetium Tc-99m albumin aggregated as a surrogate to the therapy microspheres via catheter, and undergo planar imaging. During the second visit, patients undergo a second angiography and receive yttrium Y 90 resin microspheres via arterial microcatheter. Patients then undergo single-photon emission computed tomography-computed tomography (SPECT-CT) Bremsstrahlung imaging. All subsequent patients enrolled undergo the same previously described diagnostic and treatment during 1 visit over about 8 hours. After completion of study treatment, patients are followed up at 1, 3, and 6 months.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Liver Neoplasms
• Metastatic Liver Carcinoma
• Stage IV Liver Cancer
• Stage IVA Liver Cancer
• Stage IVB Liver Cancer

Intervention

Procedure:
• Angiography
Undergo angiography
• Computed Tomography
Undergo SPECT-CT
• Planar Imaging
Undergo planar imaging

Radiation:
• Radioembolization
Undergo radioembolization

Procedure:
• Single Photon Emission Computed Tomography
Undergo SPECT-CT

Radiation:
• Technetium Tc-99m Albumin Aggregated
Given via arterial catheter

Other:
• Yttrium Y 90 Resin Microspheres
Given via arterial catheter

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success of same day yttrium Y-90 radioembolization planning and treatment angiography	Success will be defined as treatment dose calculated and patient treated on the same day of initial radiation. Feasibility will be defined as at least 9 successful same day treatments. A procedure lasting greater than 4 hours will be considered a failure. The time associated with various aspects of the same-day yttrium Y-90 radioembolization procedure will be determined. Will determine the time and cost for the patient and for MD Anderson Cancer Center between the same day yttrium Y-90-radioembolization treatment and the current standard of care two-day treatment schedule. Success status will be summarized using frequencies and percentages. Success rate will be estimated along with exact 95% confidence interval. Patient characteristics will be summarized using appropriate summary statistics.	Up to 6 months
Primary	Incidence of adverse event assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0	The summaries will be overall (severity grades 1 through 5). Actions taken for grade 3 events will also be reported. The summaries will present the number and percentage of patients reporting and adverse event for each classification level as well as the number events reported. Laboratory values will be summarized by the treatment group over time.	Up to 6 months

External Links

•   University of Texas MD Anderson Cancer Center Website