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

Sponsor
Ohio State University Comprehensive Cancer Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02119065
Collaborator
(none)
6
Enrollment
1
Location
125
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: positron emission tomography
  • Procedure: computed tomography

Detailed Description

PRIMARY OBJECTIVES:
  1. 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:
  1. 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.

Study Design

Study Type:
Observational
Actual Enrollment :
6 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
PET/CT-Derived Hepatopulmonary Shunt Fraction Following Yttrium-90 Radioembolization
Actual Study Start Date :
Jan 30, 2014
Actual Primary Completion Date :
Jul 1, 2015
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

Arm Intervention/Treatment
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.

Procedure: positron emission tomography
Undergo PET/CT scan
Other Names:
  • PET
  • PET scan
  • tomography, positron emission

    • Procedure: computed tomography
    Undergo PET/CT scan
    Other Names:
  • tomography, computed

    		•

    Outcome Measures

    Primary Outcome Measures

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

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Columbus Ohio United States 43210

    Sponsors and Collaborators

    • Ohio State University Comprehensive Cancer Center

    Investigators

    • Principal Investigator: Michael Knopp, MD, PhD, Ohio State University Comprehensive Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Michael V. Knopp MD, PhD, Principal Investigator, Ohio State University Comprehensive Cancer Center
    ClinicalTrials.gov Identifier:
    NCT02119065
    Other Study ID Numbers:
    • OSU-13176
    • NCI-2014-00278
    First Posted:
    Apr 21, 2014
    Last Update Posted:
    Apr 25, 2022
    Last Verified:
    Apr 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Michael V. Knopp MD, PhD, Principal Investigator, Ohio State University Comprehensive Cancer Center
    Yttrium-90 Radioembolization
    hepatic malignancy
    hepatic metastatic disease
    Additional relevant MeSH terms:
    Liver Neoplasms

    Study Results

    No Results Posted as of Apr 25, 2022