Clinical trial NCT02119065: Pilot Study to Assess Lung Shunting of Yttrium-90 Microspheres Using PET/CT
Official title: PET/CT-Derived Hepatopulmonary Shunt Fraction Following Yttrium-90 Radioembolization
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Advanced Adult Primary Liver Cancer
Liver Metastases
Localized Unresectable Adult Primary Liver Cancer
Recurrent Adult Primary Liver Cancer
Keywords: Yttrium-90 Radioembolization
hepatic malignancy
hepatic metastatic disease
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2014-04-21
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Absolute difference in post-therapy Yttrium-90 microsphere and pre-therapy Technetium-99m macroaggregated albumin hepatopulmonary shunt fraction values
timeFrame: Baseline to up to 36 hours after radioembolization
Secondary outcomes:
measure: In vitro Technetium-99m macroaggregated albumin particle size and microsphere size for each patient
timeFrame: Baseline up to 24 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Michael Knopp, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: