Radiation Dosimetry, Metabolism, Pharmacokinetics, Safety and Tolerability and PET Imaging With BAY94-9392 in Healthy Volunteers and Patients With Cancer or Inflammation
- Registration Number
- NCT01103310
- Lead Sponsor
- Life Molecular Imaging SA
- Brief Summary
Visual assessment of diagnostic PET/CT (positron emission tomography/computed tomography) images obtained after a single intravenous injection of BAY94-9392 in patients with cancer or inflammation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 46
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 BAY94-9392 Cancer patients, single intravenous bolus injection of 300 MBq BAY94-9392 on day one of the treatment period, PET/CT Arm 2 BAY94-9392 Healthy volunteers, single intravenous bolus injection of 300 MBq BAY94-9392 on day one of the treatment period, whole body PET/CT for determination of effective dose, kinetics of BAY94-9392 in blood
- Primary Outcome Measures
Name Time Method Visual assessment of lesion Day of study drug administration
- Secondary Outcome Measures
Name Time Method Serum creatinine At least twice within 2 days after treatment Serum protein At least twice within 2 days after treatment Quantitative analysis of BAY94-9392 uptake into lesions (Standardized Uptake Values = SUVs) Day of study drug administration Electrocardiogram (ECG) At least twice within 2 days after treatment Blood pressure At least twice within 2 days after treatment Serum GOT (Glutamate-Oxalacetate-Transaminase) At least twice within 2 days after treatment Adverse events collection Continuously for at least 4 days after treatment Radiation doses per organ (µGy/MBq) Day of study drug administration Doses per organ (µSv/MBq) Day of study drug administration Higher organ dose (HT) Day of study drug administration Effective dose (µSv/MBq) Day of study drug administration Effective dose resulting from the total administered diagnostic activity of 300 MBq +/- 10% Day of study drug administration