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Trial record 43 of 46 for:    SIR-Spheres

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02119065
Recruitment Status : Active, not recruiting
First Posted : April 21, 2014
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Michael V. Knopp MD, PhD, Ohio State University Comprehensive Cancer Center

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
Advanced Adult Primary Liver Cancer Liver Metastases Localized Unresectable Adult Primary Liver Cancer Recurrent Adult Primary Liver Cancer Procedure: positron emission tomography Procedure: computed tomography

Detailed Description:

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.


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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 : January 30, 2014
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: CT Scans
Drug Information available for: Yttrium

Group/Cohort 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 Name: tomography, computed




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The target population includes patients with unresectable liver metastases or malignancy who are referred to The Ohio State University Wexner Medical Center for Yttrium-90 microsphere radioembolization therapy.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02119065


Locations
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United States, Ohio
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
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Principal Investigator: Michael Knopp, MD, PhD Ohio State University Comprehensive Cancer Center

Additional Information:
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Responsible Party: Michael V. Knopp MD, PhD, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02119065     History of Changes
Other Study ID Numbers: OSU-13176
NCI-2014-00278 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: April 21, 2014    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019

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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, Ohio State University Comprehensive Cancer Center:
Yttrium-90 Radioembolization
hepatic malignancy
hepatic metastatic disease
Additional relevant MeSH terms:
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Liver Neoplasms
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases