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

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT00961831

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Neoplasm	Drug: F-18 (BAY85-8050) Drug: F-18 (BAY85-8050)	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

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

Study Start Date :

Apr 1, 2009

Actual Primary Completion Date :

Dec 1, 2009

Actual Study Completion Date :

Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	Drug: F-18 (BAY85-8050) Cancer patients, injection of BAY 85-8050, PET/CT
Experimental: Arm 2	Drug: 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

Arm

Intervention/Treatment

Experimental: Arm 1

Drug: F-18 (BAY85-8050)

Cancer patients, injection of BAY 85-8050, PET/CT

Experimental: Arm 2

Drug: 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

Outcome Measures

Primary Outcome Measures

Visual assessment of lesions [Within up to 2 hours after treatment]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Ulm	Baden-Württemberg	Germany	89081
2		München	Bayern	Germany	81675

Sponsors and Collaborators

Bayer

Investigators

Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bayer

ClinicalTrials.gov Identifier:

NCT00961831

Other Study ID Numbers:

13107
2008-000962-21

First Posted:

Aug 19, 2009

Last Update Posted:

Feb 20, 2014

Last Verified:

Feb 1, 2014

Keywords provided by Bayer

Neoplasm

PET/CT diagnosis

PET tracer

Additional relevant MeSH terms:

Neoplasms

Study Results

No Results Posted as of Feb 20, 2014