Trial Condition(s):

Diagnostic Imaging

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

Bayer Identifier:

14641

ClinicalTrials.gov Identifier:

NCT01089998

EudraCT Number:

2009-013098-16

Study Completed

Trial Purpose

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

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 Summary

Enrollment Goal
35
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
D-[F18]-Fluoromethyl tyrosine (BAY86-9596)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Universitair Medisch Centrum Groningen

Groningen, Netherlands, 9713 GZ

Status
Completed
 
Locations

Universitätsspital Zürich

Zürich, Switzerland, 8091

Status
Completed
 

Trial Design