check_circleStudy Completed

Diagnostic Imaging

Bayer Identifier:

14641

ClinicalTrials.gov Identifier:

NCT01089998

EudraCT Number:

2009-013098-16

EU CT Number:

Not Available
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

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

Key Participants Requirements

Sex

Both

Age

30 - 80 Years
  • - 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 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
May 2010 - September 2011
Phase
Phase 1
Could I Receive a placebo
No
Products
D-[F18]-Fluoromethyl tyrosine (BAY86-9596)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Universitair Medisch Centrum GroningenGroningen, 9713 GZ, Netherlands
Completed
Universitätsspital ZürichZürich, 8091, Switzerland

Primary Outcome

  • Visual assessment of lesions (tumor detection rate of BAY 86-9596 compared to FDG)
    date_rangeTime Frame:
    Day of study drug administration
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Quantitative analysis of BAY 86-9596 uptake into lesions (Standardized Uptake Values = SUVs)
    date_rangeTime Frame:
    Day of study drug administration
    enhanced_encryption
    Safety Issue:
    no
  • Vital signs (ECG, blood pressure, Heart rate, Body temperature)
    date_rangeTime Frame:
    At least 2 times within 8 days after treatment
    enhanced_encryption
    Safety Issue:
    yes
  • Serum chemistry, Clotting status, Hematology
    date_rangeTime Frame:
    At least 2 times within 8 days after treatment
    enhanced_encryption
    Safety Issue:
    yes
  • Adverse Event collection
    date_rangeTime Frame:
    At least 2 times within 8 days after treatment
    enhanced_encryption
    Safety Issue:
    yes

Trial design

Open-label, multicenter study of the 18F-labeled PET/CT (positron emission tomography / computed tomography) tracer BAY86-9596 following a single intravenous administration of 200 or 300 MBq (corresponding to ≤ 18 µg mass dose) for evaluation of radiation dosimetry, plasma pharmacokinetics, safety and tolerability in healthy volunteers (200 MBq) as well as investigation of safety, tolerability and diagnostic performance in patients (300 MBq) with non-small cell lung cancer, breast cancer, head and neck cancer and in patients with inflammation.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Diagnostic
Allocation
Non-randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
4

Additional Information

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