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.

Life Molecular Imaging SA0 sites46 target enrollmentApril 2010

ConditionsDiagnostic Imaging Neoplasms

InterventionsBAY94-9392

DrugsBAY94-9392

Overview

Phase: Phase 1
Intervention: BAY94-9392
Conditions: Diagnostic Imaging
Sponsor: Life Molecular Imaging SA
Enrollment: 46
Primary Endpoint: Visual assessment of lesion
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2010

End Date

August 2011

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Life Molecular Imaging SA

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

Arm 1

Cancer patients, single intravenous bolus injection of 300 MBq BAY94-9392 on day one of the treatment period, PET/CT

Intervention: BAY94-9392

Arm 2

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

Intervention: BAY94-9392

Outcomes

Primary Outcomes

Visual assessment of lesion

Time Frame: Day of study drug administration

Secondary Outcomes

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)
Radiation doses per organ (µGy/MBq)(Day of study drug administration)
Serum GOT (Glutamate-Oxalacetate-Transaminase)(At least twice within 2 days after treatment)
Adverse events collection(Continuously for at least 4 days after treatment)
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)