Radiation Dosimetry, Metabolism, Safety, Tolerability and Positron Emission Tomography/Computed Tomography (PET/CT) Imaging With BAY 85-8050 in Healthy Volunteers and Patients

Phase 1

Completed

• Conditions: Neoplasm
• Interventions: Drug: F-18 (BAY85-8050)

• Registration Number: NCT00961831
• Lead Sponsor: Bayer

Brief Summary

This study is a visual assessment of diagnostic PET/CT images obtained after a single intravenous injection of BAY85-8050 in patients with cancer

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2009-04-15
• Study First Submitted: 2009-08-18
• Study First Submitted QC: 2009-08-18
• Study First Posted: 2009-08-19
• Primary Completion: 2009-12-16
• Study Completion: 2009-12-16
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-07
• Last Update Posted: 2022-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Healthy volunteers only
• Males/females, >/=50 and </= 65 years of age
• Cancer patients only
• Males/females >/= 35 years and </= 75 years of age
• Patient had an FDG PET/CT for detection, or staging, or restaging, or therapy response assessment that still showed tumor mass

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Exclusion Criteria

• Concurrent severe and/or uncontrolled and/or unstable other medical disease (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 12 months prior to planned injection of BAY85-8050, unstable and uncontrolled hypertension, chronic renal or hepatic disease, severe pulmonary disease) which could compromise participation in the study
• Known sensitivity to the study drug or components of the preparation

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	F-18 (BAY85-8050)	-
Arm 2	F-18 (BAY85-8050)	-

Primary Outcome Measures

Name	Time	Method
Visual assessment of lesions	Within up to 2 hours after treatment

Secondary Outcome Measures

Name	Time	Method
Quantitative analysis of BAY 85-8050 uptake into lesions (Standardized Uptake Values, SUVs)	Within up to 2 hours after treatment
Serum chemistry:Glutamate pyruvate transaminase (GPT/ALAT), gamma-glutamyl transferase (gamma-GT), glutamate-oxaloacetate transaminase (GOT), alkaline phosphatase, total bilirubin, creatinine, total protein	At least 2 times within 8 days after treatment
Electrocardiogram (ECG)	at least 2 times within 8 days after treatment
Vital signs: Heart rate, blood pressure	at least 2 times within 8 days after treatment
Adverse events collection	continuously for at least 8 days after treatment