Clinical trial NCT01089998: 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
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diagnostic Imaging
Keywords: Neoplasm
PET/CT diagnosis
PET tracer
Inflammation
Lead sponsor: Life Molecular Imaging SA
Sponsor class: INDUSTRY
First posted: 2010-03-19
Enrollment: 35
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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


Eligibility criteria: 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:

* Exclusion criteria for all healthy volunteers and patients:

  * any concomitant disease (for healthy volunteers) and for patients any 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 BAY86-9596, unstable and uncontrolled hypertension, chronic renal or hepatic disease, severe pulmonary disease) which could compromise participation in the study
  * For healthy volunteers and patients: known sensitivity to the study drug or components of the preparation.
  * tumor patients with known inflammatory disease, where images overlap inflammatory lesions with tumor lesions

Primary outcomes:
measure: Visual assessment of lesions (tumor detection rate of BAY 86-9596 compared to FDG)
timeFrame: Day of study drug administration
Secondary outcomes:
measure: Quantitative analysis of BAY 86-9596 uptake into lesions (Standardized Uptake Values = SUVs)
timeFrame: Day of study drug administration
measure: Vital signs (ECG, blood pressure, Heart rate, Body temperature)
timeFrame: At least 2 times within 8 days after treatment
measure: Serum chemistry, Clotting status, Hematology
timeFrame: At least 2 times within 8 days after treatment
measure: Adverse Event collection
timeFrame: At least 2 times within 8 days after treatment
Other outcomes:
Locations:
city: Groningen
country: Netherlands
city: Zürich
country: Switzerland
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: