PET/CT Imaging for Radiation Dosimetry, Plasma Pharmacokinetics, Safety and Tolerability in Healthy Volunteers and Safety, Tolerability and Diagnostic Performance of BAY86-9596 in Patients With Non-small Cell Lung Cancer, Breast Cancer, Head and Neck Cancer and Patients With Inflammations

Open-label, Multicenter Study of the 18F-labeled PET/CT (Positron Emission Tomography / Computed Tomography) Tracer BAY86-9596 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 Lung Cancer, Breast Cancer, Head and Neck Cancer and in Patients With Inflammation.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01089998

Enrollment

Registered

2010-03-19

Start date

2010-05-31

Completion date

2011-09-30

Last updated

2013-01-21

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

Conditions

Diagnostic Imaging

Keywords

Neoplasm, PET/CT diagnosis, PET tracer, Inflammation

Brief summary

Visual assessment of diagnostic PET/CT (positron emission tomography/computed tomography) images obtained after a single intravenous injection of BAY86-9596 in patients with cancer and inflammation

Interventions

DRUGBAY86-9596

Healthy volunteers, single intravenous bolus injection of 200 MBq BAY 86-9596 on day one of the treatment period, whole body PET/CT for determination of effective dose, kinetics of BAY 86-9596 in blood and urine

DRUGFludeoxyglucose (18F)-IBA

Subgroup of cancer patients: radiation induced inflammation. Fluordeoxyglucose (18F)-FDG PET scan will be performed approx. 4 week after radiation and compared with tracer BAY86-9596 (acc. to Amendment 4 only in the Netherlands)

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

30 Years to 80 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy volunteers only * Males/females ≥ 50 years and ≤ 65 years of age * Cancer patients and inflammation patients (inflammation patients in study part 2 = optional, in study part 3 mandatory) * Males/females ≥ 30 and ≤ 80 years of age * patients had an FDG PET/CT for detection, or staging, or restaging, or therapy response assessment that still showed tumor mass with high certainty, for 1. NSCLC (non small cell lung cancer), or 2. adenocarcinoma of the breast (female patients) or 3. squamous cell cancer of head and neck and the cancer disease is histologically confirmed. 4. Patients with confirmed/known inflammatory focus/foci after FDG-PET/CT imaging

Exclusion criteria

Design outcomes

Primary

Measure	Time frame
Visual assessment of lesions (tumor detection rate of BAY 86-9596 compared to FDG)	Day of study drug administration

Secondary

Measure	Time frame
Quantitative analysis of BAY 86-9596 uptake into lesions (Standardized Uptake Values = SUVs)	Day of study drug administration
Vital signs (ECG, blood pressure, Heart rate, Body temperature)	At least 2 times within 8 days after treatment
Serum chemistry, Clotting status, Hematology	At least 2 times within 8 days after treatment
Adverse Event collection	At least 2 times within 8 days after treatment

Countries

Netherlands, Switzerland

Outcome results

None listed

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