Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_1

Timeline

8mo left

Started Jan 2017

Longer than P75 for phase_1

Geographic Reach

1 country

1 active site

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

10.1 years study duration

Study Progress93%

Jan 2017Jan 2027

Study Start

First participant enrolled

January 9, 2017

Completed

10 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2017

Completed

4 days until next milestone

First Posted

Study publicly available on registry

January 23, 2017

Completed

10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

10.1 years

First QC Date

January 19, 2017

Last Update Submit

March 6, 2026

Conditions

Metastatic Liver Carcinoma Stage IV Liver Cancer Stage IVA Liver Cancer Stage IVB Liver Cancer

Outcome Measures

Primary Outcomes (2)

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
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

Study Arms (1)

Treatment (angiography, yttrium Y-90 radioembolization)

OTHER

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.

Procedure: AngiographyProcedure: Computed TomographyProcedure: Planar ImagingRadiation: RadioembolizationProcedure: Single Photon Emission Computed TomographyRadiation: Technetium Tc-99m Albumin AggregatedOther: Yttrium Y 90 Resin Microspheres