stop_circleTerminated/Withdrawn

Diagnostic imaging

Bayer Identifier:

13991

ClinicalTrials.gov Identifier:

NCT00975299

EudraCT Number:

2008-007460-42

EU CT Number:

Not Available
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

Trial purpose

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

Key Participants Requirements

Sex

Male

Age

45 Years
  • - 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 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.

Trial summary

Enrollment Goal
16
Trial Dates
September 2009 - October 2010
Phase
Phase 1
Could I Receive a placebo
No
Products
Bombesin (18F) labeled (BAY86-4367)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Universitätsspital ZürichZürich, 8091, Switzerland
Completed
Klinikum rechts der IsarMünchen, 81675, Germany

Primary Outcome

  • Visual assessment of lesions
    date_rangeTime Frame:
    Day of study drug administration
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Quantitative analysis of BAY86-4367 uptake into lesions (Standardized Uptake Values = SUVs)
    date_rangeTime Frame:
    Day of study drug administration
    enhanced_encryption
    Safety Issue:
    no
  • Electrocardiogram (ECG)
    date_rangeTime Frame:
    At least 3 times within 8 days after treatment
    enhanced_encryption
    Safety Issue:
    yes
  • Blood pressure
    date_rangeTime Frame:
    At least 3 times within 8 days after treatment
    enhanced_encryption
    Safety Issue:
    yes
  • Serum protein
    date_rangeTime Frame:
    At least 3 times within 8 days after treatment
    enhanced_encryption
    Safety Issue:
    yes
  • Serum creatinine
    date_rangeTime Frame:
    At least 3 times within 8 days after treatment
    enhanced_encryption
    Safety Issue:
    yes
  • Serum GOT (Glutamat-Oxalacetat-Transaminase)
    date_rangeTime Frame:
    At least 3 times within 8 days after treatment
    enhanced_encryption
    Safety Issue:
    yes
  • Adverse events collection
    date_rangeTime Frame:
    At least 3 times within 8 days after treatment
    enhanced_encryption
    Safety Issue:
    yes

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Diagnostic
Allocation
Non-randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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