NCT03028311

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

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	Angiography	Undergo angiography
PROCEDURE	Computed Tomography	Undergo SPECT-CT
PROCEDURE	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

Timeline

• Start date: 2017-01-09
• Primary completion: 2027-01-31
• Completion: 2027-01-31
• First posted: 2017-01-23
• Last updated: 2026-03-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study