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

Life Molecular Imaging

Status and phase: Completed; Phase 1

Conditions: Diagnostic Imaging

Treatments: Drug: Fludeoxyglucose (18F)-IBA; Drug: BAY86-9596

Study type: Interventional

Funder types: Industry

Identifiers

NCT01089998

14641

2009-013098-16 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 35 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 4 patient groups

Arm 1

Experimental group

Treatment:

Drug: BAY86-9596

Drug: BAY86-9596

Drug: BAY86-9596

Arm 2

Experimental group

Treatment:

Drug: BAY86-9596

Drug: BAY86-9596

Drug: BAY86-9596

Arm 3

Experimental group

Treatment:

Drug: BAY86-9596

Drug: BAY86-9596

Drug: BAY86-9596

Arm 4

Experimental group

Treatment:

Drug: Fludeoxyglucose (18F)-IBA