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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.


Phase 1
30 Years
80 Years
Not Enrolling
Both
Diagnostic Imaging

Thank you

Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Visual assessment of lesions (tumor detection rate of BAY 86-9596 compared to FDG)

Outcome Time Frame:

Day of study drug administration

Safety Issue:

No

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

Nederlands: CCMO=Centrale Commissie Mensgebonden Onderzoek (Central Committee on Research inv. Human Subjects)

Study ID:

14641

NCT ID:

NCT01089998

Start Date:

May 2010

Completion Date:

September 2011

Related Keywords:

  • Diagnostic Imaging
  • Neoplasm
  • PET/CT diagnosis
  • PET tracer
  • Inflammation
  • Breast Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Head and Neck Neoplasms
  • Inflammation
  • Lung Neoplasms

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