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Clinical trial

Open-label, Multi Center Study for an Evaluation of Radiation Dosimetry, Plasma Pharmacokinetics, Safety and Tolerability of the 18F-labeled PET/CT (Positron Emission Tomography / Computed Tomography) Tracer BAY94-9392 Following a Single Intravenous Administration of 300 MBq (Corresponding to ≤ 100 µg Total Quantity) in Healthy Volunteers, as Well as the Investigation of Safety, Tolerability, Pharmacokinetics, and Diagnostic Performance of the Tracer in PET/CT in Cancer Patients or Patients With Inflammation.

NCT01103310 is registered in ClinicalTrials.gov with Lantheus Biosciences Ltd. as lead sponsor.

NCT NCT01103310
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Registry record

As filed in ClinicalTrials.gov.

Title
Open-label, Multi Center Study for an Evaluation of Radiation Dosimetry, Plasma Pharmacokinetics, Safety and Tolerability of the 18F-labeled PET/CT (Positron Emission Tomography / Computed Tomography) Tracer BAY94-9392 Following a Single Intravenous Administration of 300 MBq (Corresponding to ≤ 100 µg Total Quantity) in Healthy Volunteers, as Well as the Investigation of Safety, Tolerability, Pharmacokinetics, and Diagnostic Performance of the Tracer in PET/CT in Cancer Patients or Patients With Inflammation.
Lead sponsor
Lantheus Biosciences Ltd.
Phase
Phase 1
Overall status
Completed
Start date
April 30, 2010
Completion date
August 31, 2011
Enrollment
46 (actual)
Sites
3

Conditions

As the registry lists them; a condition with its own page is linked.

diagnostic imaging, neoplasms