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Active, Not Recruiting

NCT Number: NCT02119065

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Advanced Adult Primary Liver Cancer Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Metastases Liver Neoplasms Localized Unresectable Adult Primary Liver Cancer Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Recurrent Adult Primary Liver Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Positron Emission Tomography

Procedure

Undergo PET/CT scan

Other names: PET, PET scan, tomography, positron emission

Computed Tomography

Procedure

Undergo PET/CT scan

Other names: tomography, computed

Primary outcomes

  1. Absolute difference in post-therapy Yttrium-90 microsphere and pre-therapy Technetium-99m macroaggregated albumin hepatopulmonary shunt fraction values

    Time frame: Baseline to up to 36 hours after radioembolization

    Non-parametric Wilcoxon signed rank testing will be used to compare the 99mTc MAA and 90Y microsphere shunt fractions. Alternatively, a natural log transformation of the hepatopulmonary shunt fractions may be used to normalize these data for subsequent parametric paired t-test analysis.

Secondary outcomes

  1. In vitro Technetium-99m macroaggregated albumin particle size and microsphere size for each patient

    Time frame: Baseline up to 24 months

    Descriptive statistical assessment of Technetium-99m macroaggregated albumin particle size and microsphere size for each patient (e.g., mean, median, standard deviation, distribution, etc.) will be performed.

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Registry information

Official study title

PET/CT-Derived Hepatopulmonary Shunt Fraction Following Yttrium-90 Radioembolization

Important dates

Study start
2014
Primary completion
2015
Study completion
2026
First posted
Apr 21, 2014
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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