Yttrium Y-90 Radioembolization in Treating Patients With Metastatic Liver Cancer
NCT ID: NCT03028311
Last Updated: 2025-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
12 participants
INTERVENTIONAL
2017-01-09
2027-01-31
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
Study Groups
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Treatment (angiography, yttrium Y-90 radioembolization)
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.
Angiography
Undergo angiography
Computed Tomography
Undergo SPECT-CT
Planar Imaging
Undergo planar imaging
Radioembolization
Undergo radioembolization
Single Photon Emission Computed Tomography
Undergo SPECT-CT
Technetium Tc-99m Albumin Aggregated
Given via arterial catheter
Yttrium Y 90 Resin Microspheres
Given via arterial catheter
Interventions
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Angiography
Undergo angiography
Computed Tomography
Undergo SPECT-CT
Planar Imaging
Undergo planar imaging
Radioembolization
Undergo radioembolization
Single Photon Emission Computed Tomography
Undergo SPECT-CT
Technetium Tc-99m Albumin Aggregated
Given via arterial catheter
Yttrium Y 90 Resin Microspheres
Given via arterial catheter
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Any candidate eligible for standard of care Y90 radioembolization for treatment of their primary or metastatic liver tumors
Exclusion Criteria
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Armeen Mahvash
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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University of Texas MD Anderson Cancer Center Website
Other Identifiers
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NCI-2017-00629
Identifier Type: REGISTRY
Identifier Source: secondary_id
2016-0244
Identifier Type: OTHER
Identifier Source: secondary_id
2016-0244
Identifier Type: -
Identifier Source: org_study_id
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