Trial Condition(s):

Neoplasm

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

Bayer Identifier:

13107

ClinicalTrials.gov Identifier:

NCT00961831

EudraCT Number:

2008-000962-21

Study Completed

Trial Purpose

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

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

Trial Summary

Enrollment Goal
20
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
F18 Glutamic Acid (BAY85-8050)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

München, Germany, 81675

Status
Completed
 

Trial Design