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

NCT ID: NCT03028311

Last Updated: 2025-09-11

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-09

Study Completion Date

2027-01-31

Brief Summary

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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

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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

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

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.

Group Type OTHER

Angiography

Intervention Type PROCEDURE

Undergo angiography

Computed Tomography

Intervention Type PROCEDURE

Undergo SPECT-CT

Planar Imaging

Intervention Type PROCEDURE

Undergo planar imaging

Radioembolization

Intervention Type RADIATION

Undergo radioembolization

Single Photon Emission Computed Tomography

Intervention Type PROCEDURE

Undergo SPECT-CT

Technetium Tc-99m Albumin Aggregated

Intervention Type RADIATION

Given via arterial catheter

Yttrium Y 90 Resin Microspheres

Intervention Type OTHER

Given via arterial catheter

Interventions

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Angiography

Undergo angiography

Intervention Type PROCEDURE

Computed Tomography

Undergo SPECT-CT

Intervention Type PROCEDURE

Planar Imaging

Undergo planar imaging

Intervention Type PROCEDURE

Radioembolization

Undergo radioembolization

Intervention Type RADIATION

Single Photon Emission Computed Tomography

Undergo SPECT-CT

Intervention Type PROCEDURE

Technetium Tc-99m Albumin Aggregated

Given via arterial catheter

Intervention Type RADIATION

Yttrium Y 90 Resin Microspheres

Given via arterial catheter

Intervention Type OTHER

Other Intervention Names

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CAT CAT Scan Computerized Axial Tomography computerized tomography CT CT SCAN tomography intra-arterial brachytherapy Medical Imaging, Single Photon Emission Computed Tomography Single Photon Emission Tomography single-photon emission computed tomography SPECT SPECT imaging SPECT SCAN SPET tomography, emission computed, single photon Tomography, Emission-Computed, Single-Photon Tc 99m-labeled MAA Technetium Tc 99m-Labeled Macroaggregated Albumin Technetium Tc-99m Albumin Colloid SIR-Spheres

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

Related Links

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http://www.mdanderson.org

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

P30CA016672

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2016-0244

Identifier Type: -

Identifier Source: org_study_id

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