Clinical trial NCT01205321: PET/CT Imaging for Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Tolerability and Diagnostic Performance of BAY86-7548 in Patients With Prostate Cancer and Healthy Volunteers
Official title: Open-label, Multi Center PET/CT (Positron Emission Tomography/Computed Tomography) Study for Investigation of Safety, Tolerability, Biodistribution and Diagnostic Performance of the 68Ga Labeled PET Tracer BAY86-7548 Following a Single Intravenous Administration of 140 MBq (Corresponding to ≤ 28 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: COMPLETED
Phase: PHASE1
Conditions: Diagnostic Imaging
Keywords: Neoplasm
PET/CT diagnosis
PET tracer
Lead sponsor: Life Molecular Imaging SA
Sponsor class: INDUSTRY
First posted: 2010-09-20
Enrollment: 19
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: 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 BAY86-7548 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 had an MRI of the prostate and/or a positive choline or acetate PET/CT for diagnosis (Note: MRI, choline and acetate PET/CT are optional for primary prostate cancer patients) of recurrence prostate cancer and the primary cancer disease is/ will be histologically confirmed.
  * The prostate cancer is histologically confirmed and results of histology are available.
  * Patients with primary prostate cancer: \>/= 20 percent of biopsy material should be affected by cancer in the histopathological evaluation.
  * Patients with primary prostate cancer: Patient is scheduled to undergo prostatectomy.

Exclusion Criteria:

* 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 BAY86-7548, 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 BAY86-7548 uptake into lesions (Standardized Uptake Values = SUVs)
timeFrame: Day of study drug administration
measure: ECG (significant abnormalities)
timeFrame: At least 3 times until one day after treatment
measure: Blood pressure
timeFrame: At least 3 times until one day after treatment
measure: Serum protein
timeFrame: At least 3 times until one day after treatment
measure: Serum creatinine
timeFrame: At least 3 times until one day after treatment
measure: Serum GOT (Glutamat-Oxalacetat-Transaminase)
timeFrame: At least 3 times until one day after treatment
measure: Adverse events collection
timeFrame: Continuously for at least 5 days after treatment
Other outcomes:
Locations:
city: Turku
country: Finland
city: Ulm
country: Germany
state: Baden-Württemberg
city: Zürich
country: Switzerland
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: