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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00961831

Enrollment

Registered

2009-08-19

Start date

2009-04-15

Completion date

2009-12-16

Last updated

2022-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasm

Keywords

Neoplasm, PET/CT diagnosis, PET tracer

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

Interventions

DRUGF-18 (BAY85-8050)

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

35 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
Visual assessment of lesions	Within up to 2 hours after treatment

Secondary

Measure	Time frame
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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026