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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Lantheus Biosciences Ltd.
Age
30–80
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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
You may not be if
* 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
Clareo Health | 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
