Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00004044

Trial Description

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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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00004044
  •   2012/07/16
  •   2010/09/17
  •   no
  •   [---]*
  •   [---]*
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Secondary IDs

  •   2008-008315-25 
  •   NCT01205321  (ClinicalTrials.gov)
  •   14269  (Bayer)
  •   2008-008315-25 
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Health Condition or Problem studied

  •   Diagnostic Imaging
  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   Drug: Bombesin (68Ga) labeled (BAY86-7548)
  •   Drug: Bombesin (68Ga) labeled (BAY86-7548)
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Diagnostic
  •   Parallel
  •   I
  •   [---]*
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Primary Outcome

- Visual assessment of lesions; time frame: Day of study drug administration

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Secondary Outcome

- Quantitative analysis of BAY86-7548 uptake into lesions (Standardized Uptake Values = SUVs); time frame: Day of study drug administration
- ECG (significant abnormalities); time frame: At least 3 times until one day after treatment
- Blood pressure; time frame: At least 3 times until one day after treatment
- Serum protein; time frame: At least 3 times until one day after treatment
- Serum creatinine; time frame: At least 3 times until one day after treatment
- Serum GOT (Glutamat-Oxalacetat-Transaminase); time frame: At least 3 times until one day after treatment
- Adverse events collection; time frame: Continuously for at least 5 days after treatment

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Countries of Recruitment

  •   Finland
  •   Germany
  •   Switzerland
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Locations of Recruitment

  •  
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Recruitment

  •   [---]*
  •   2010/11/30
  •   19
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Male
  •   45   Years
  •   no maximum age
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Additional 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.

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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.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Piramal Imaging SA
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    • Bayer
    • Bayer Study Director 
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    •   [---]*
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    •   [---]*
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    • Bayer
    • Bayer Study Director 
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2011/12/01
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   5
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.