Open-label, multicenter study of the 18F labeled PET/CT (positron emission tomography / computed tomography) tracer BAY 86-9596 following a single intravenous administration of 200 or 300 MBq (corresponding to <= 18 µg mass dose), for evaluation of radiation dosimetry, plasma pharmacokinetics, safety and tolerability in healthy volunteers (200 MBq) as well as investigation of safety, tolerability and diagnostic performance in patients (300 MBq) with non small cell long cancer, breast cancer, hea

Open-label, multicenter study of the 18F labeled PET/CT (positron emission tomography / computed tomography) tracer BAY 86-9596 following a single intravenous administration of 200 or 300 MBq (corresponding to <= 18 µg mass dose), for evaluation of radiation dosimetry, plasma pharmacokinetics, safety and tolerability in healthy volunteers (200 MBq) as well as investigation of safety, tolerability and diagnostic performance in patients (300 MBq) with non small cell long cancer, breast cancer, hea - D-FMT: PET-POM study (proof of mechanism)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON57022

Enrollment

Registered

2010-02-25

Start date

2010-06-09

Completion date

Unknown

Last updated

2024-10-07

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

Conditions

Healthy volunteers, patients with cancer, patients with inflammation Cancer malignant neoplasm

Interventions

The study will start with a screening. At the screening a physical examination will take place and a few other standard medical assessments will be performed (ECG, vital signs). Furthermore a blood

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy male or female volunteers between 50 and 65 years of age Male or female cancer patients between 30 and 80 years of age Male or female patients with inflammation between 35 and 75 years of age

Exclusion criteria

Exclusion criteria: Healthy volunteers: clinical significant abnormalities at medical examinations Patienten: concurrent severe and/or uncontrolled and/or unstable medical disease other than cancer or inflammation which could compromise participation in the study

Design outcomes

Primary

Measure	Time frame
Explorative investigation of the tumor detection rate with BAY 86-9596 in comparison to that of 18F-fluorodeoxyglucose (FDG)	—

Secondary

Measure	Time frame
- Determination of radiation dosimetry and pharmacokinetics of BAY 86-9596 in healthy volunteers as well as orientating search for any metabolites using TLC - Evaluation of BAY 86-9596 compared to FDG in patients with cancer and inflammation - Evaluation of safety and tolerability of BAY 86-9596 in patients and healthy volunteers	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)