Status:
TERMINATED
Abelcet Radiotagging Protocol: Inhaled Lipid Complex Abelcet® in Lung Transplant Recipients
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
Enzon Pharmaceuticals, Inc.
Conditions:
Lung Transplantation
Lung Diseases
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to quantify the dose of aerosol medication deposited in the lungs of lung transplant recipients receiving a single nebulized treatment of aerosolized Abelcet® (lipid compl...
Detailed Description
Research Methods: The patient will need to complete one visit that will take about 3 hours of their time. All testing will be performed in the Nuclear Medicine Department located on the first floor o...
Eligibility Criteria
Inclusion
- Single or double lung transplant recipients
- Age \> 18
- Willing to be available at the testing center
- Able to understand and complete informed consent
Exclusion
- Pregnant women, or women capable of bearing children who will not perform urine pregnancy test.
- Nursing mothers.
- Hypersensitivity to amphotericin B (Abelcet®) or technetium \[Tc-99m\] based radiopharmaceuticals.
- Subjects with a past history of bronchospasm associated with aerosol drug use
- Subjects with active bacterial or viral infection as defined by the current use of non-prophylactic antibiotic anti-viral medications
- Subjects with an FEV1 \< 30% predicted or forced vital capacity (FVC) % predicted \< 30%
- Subjects requiring supplemental oxygen
- Receipt of inhalational or IV amphotericin B within last 30 days
- Subjects with known fungal infection, as per Mycoses Study Group (MSG) criteria, on therapy with antifungal drugs or diagnosed on the day of bronchoscopy
- Serum creatinine \> 1.9 mg/dl on the day of clinic visit
- Liver enzymes ALT/AST/alk phos greater than two times the normal limit
- Concurrent intravenous aminoglycoside use
- Subjects with fever \> 38.2°C
- Subjects on mechanical ventilation.
- Have participated in any studies involving radiopharmaceuticals within 14 days.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
End Date :
April 1 2006
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00235651
Start Date
October 1 2005
End Date
April 1 2006
Last Update
December 17 2008
Active Locations (1)
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1
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213