Clinical trial NCT00975299: Positron Emission Tomography/Computed Tomography (PET/CT) Imaging for Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Tolerability and Diagnostic Performance of BAY86-4367 in Patients With Prostate Cancer and Healthy Volunteers
Official title: Open-label, Multicenter PET/CT (Positron Emission Tomography/Computed Tomography) Study for Investigation of Safety, Tolerability, Biodistribution and Diagnostic Performance of the 18F Labeled PET Tracer BAY86-4367 Following a Single Intravenous Administration of 300 MBq (Corresponding to </= 40 µg Mass Dose) in Patients With Prostate Cancer as Well as Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Tolerability of the Tracer in PET/CT in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Diagnostic Imaging
Keywords: Neoplasm
PET/CT diagnosis
PET tracer
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-09-11
Enrollment: 16
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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 BAY86-4367 in patients with cancer


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers:

  * males, \>/=50 and \<= 65 years of age
* Cancer patients:

  * males \>/= 45 years of age
  * patients with recurrent prostate cancer had a positive choline PET/CT for detection, or staging, or restaging of cancer, evaluation of the primary prostate cancer detection rate with BAY 86-4367 in comparison to histology as standard of truth (choline PET/CT is optional).

Exclusion Criteria:

* Exclusion criteria for all healthy volunteers and patients:

  * 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 BAY 86-4367, unstable and uncontrolled hypertension, chronic renal or hepatic disease, severe pulmonary disease) which could compromise participation in the study
  * Known sensitivity to the study drug or components of the preparation.

Primary outcomes:
measure: Visual assessment of lesions
timeFrame: Day of study drug administration
Secondary outcomes:
measure: Quantitative analysis of BAY86-4367 uptake into lesions (Standardized Uptake Values = SUVs)
timeFrame: Day of study drug administration
measure: Electrocardiogram (ECG)
timeFrame: At least 3 times within 8 days after treatment
measure: Blood pressure
timeFrame: At least 3 times within 8 days after treatment
measure: Serum protein
timeFrame: At least 3 times within 8 days after treatment
measure: Serum creatinine
timeFrame: At least 3 times within 8 days after treatment
measure: Serum GOT (Glutamat-Oxalacetat-Transaminase)
timeFrame: At least 3 times within 8 days after treatment
measure: Adverse events collection
timeFrame: At least 3 times within 8 days after treatment
Other outcomes:
Locations:
city: München
country: Germany
state: Bayern
city: Zürich
country: Switzerland
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: