Pilot Study to Assess Lung Shunting of Yttrium-90 Microspheres Using PET/CT

NCT ID: NCT02119065

Last Updated: 2025-04-11

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

Total Enrollment

6 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-30

Study Completion Date

2026-12-31

Brief Summary

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This pilot clinical trial studies positron emission tomography (PET)/computed tomography (CT) in finding beads after Yttrium-90 bead therapy in patients with primary liver cancer or cancer that has spread to the liver (metastatic) that can not be removed by surgery. Imaging procedures, such as PET/CT after Yttrium-90 bead therapy, may help see if the beads are present in the lung and compare the results with the pre-therapy imaging.

Detailed Description

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PRIMARY OBJECTIVES:

I. To estimate the absolute difference in post-therapy Yttrium-90 microsphere hepatopulmonary shunt fraction and the pre-therapy Technetium-99m macroaggregated albumin hepatopulmonary shunt fraction in patients with unresectable primary hepatic malignancy and hepatic metastatic disease.

SECONDARY OBJECTIVES:

I. To quantify and compare the pre-therapy Technetium-99m macroaggregated albumin particle sizes and post-therapy Yttrium-90 microsphere sizes.

OUTLINE:

Patients receive routine pre-therapy Technetium-99m macroaggregated albumin. Patients then undergo routine radioembolization with Yttrium-90 microspheres. Within 36 hours after radioembolization, patients undergo PET/CT imaging.

Available imaging, clinical, interventional and surgical follow-up data for 2 years after completion of enrollment in the study will be obtained.

Conditions

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Advanced Adult Primary Liver Cancer Liver Metastases Localized Unresectable Adult Primary Liver Cancer Recurrent Adult Primary Liver Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Health Services Research (PET/CT scan)

Patients receive routine pre-therapy technetium Tc 99m-labeled macroaggregated albumin. Patients then undergo routine radioembolization with yttrium Y 90 resin microspheres. Within 36 hours after radioembolization, patients undergo PET/CT imaging.

positron emission tomography

Intervention Type PROCEDURE

Undergo PET/CT scan

computed tomography

Intervention Type PROCEDURE

Undergo PET/CT scan

Interventions

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positron emission tomography

Undergo PET/CT scan

Intervention Type PROCEDURE

computed tomography

Undergo PET/CT scan

Intervention Type PROCEDURE

Other Intervention Names

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PET PET scan tomography, positron emission tomography, computed

Eligibility Criteria

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Inclusion Criteria

* Patients who undergo intra-arterial hepatic 99mTc MAA evaluation in anticipation of 90Y microsphere radioembolization

Exclusion Criteria

* Patients who are unable to give consent
* Prisoners
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Michael V Knopp MD PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Knopp, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University Comprehensive Cancer Center

Locations

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Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Columbus, Ohio, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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NCI-2014-00278

Identifier Type: REGISTRY

Identifier Source: secondary_id

OSU-13176

Identifier Type: -

Identifier Source: org_study_id

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