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

Neoplasm Clinical Trial

Official title:

Open-label, Multicenter Study for an Evaluation of Radiation Dosimetry, Metabolism, Safety and Tolerability of the [F18] Labeled PET (Positron Emission Tomography) Tracer BAY 85-8050 Following a Single Intravenous Administration in Healthy Volunteers, as Well as the Investigation of Safety, Tolerability and Diagnostic Performance of the Tracer in PET/CT (Computer Tomography) in Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00961831
• Other study ID #: 13107
• Secondary ID: 2008-000962-21
• Status: Completed
• Phase: Phase 1
• Start date: April 15, 2009
• Est. completion date: December 16, 2009

Study information

• Verified date: October 2022
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 16, 2009
• Est. primary completion date: December 16, 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Neoplasm
• Neoplasms

Intervention

Drug:
• F-18 (BAY85-8050)
Cancer patients, injection of BAY 85-8050, PET/CT
• F-18 (BAY85-8050)
Healthy volunteers, injection of BAY 85-8050, whole body PET/CT for determination of effective dose, kinetics of BAY 85-8050 in blood

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual assessment of lesions		Within up to 2 hours after treatment
Secondary	Quantitative analysis of BAY 85-8050 uptake into lesions (Standardized Uptake Values, SUVs)		Within up to 2 hours after treatment
Secondary	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
Secondary	Electrocardiogram (ECG)		at least 2 times within 8 days after treatment
Secondary	Vital signs: Heart rate, blood pressure		at least 2 times within 8 days after treatment
Secondary	Adverse events collection		continuously for at least 8 days after treatment

External Links

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