check_circleStudy Completed

Neoplasm

Bayer Identifier:

13107

ClinicalTrials.gov Identifier:

NCT00961831

EudraCT Number:

2008-000962-21

EU CT Number:

Not Available
Radiation Dosimetry, Metabolism, Safety, Tolerability and Positron Emission Tomography/Computed Tomography (PET/CT) Imaging With BAY 85-8050 in Healthy Volunteers and Patients

Trial purpose

This study is a visual assessment of diagnostic PET/CT images obtained after a single intravenous injection of BAY85-8050 in patients with cancer

Key Participants Requirements

Sex

Both

Age

35 - 75 Years
  • - Healthy volunteers only
    - Males/females, >/=50 and - Cancer patients only
    - Males/females >/= 35 years and - Patient had an FDG PET/CT for detection, or staging, or restaging, or therapy response assessment that still showed tumor mass
  • - 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 BAY85-8050, 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
20
Trial Dates
April 2009 - December 2009
Phase
Phase 1
Could I Receive a placebo
No
Products
F18 Glutamic Acid (BAY85-8050)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
München, 81675, Germany

Primary Outcome

  • Visual assessment of lesions
    date_rangeTime Frame:
    Within up to 2 hours after treatment
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Quantitative analysis of BAY 85-8050 uptake into lesions (Standardized Uptake Values, SUVs)
    date_rangeTime Frame:
    Within up to 2 hours after treatment
    enhanced_encryption
    Safety Issue:
    no
  • Serum chemistry:Glutamate pyruvate transaminase (GPT/ALAT), gamma-glutamyl transferase (gamma-GT), glutamate-oxaloacetate transaminase (GOT), alkaline phosphatase, total bilirubin, creatinine, total protein
    date_rangeTime Frame:
    At least 2 times within 8 days after treatment
    enhanced_encryption
    Safety Issue:
    yes
  • Electrocardiogram (ECG)
    date_rangeTime Frame:
    at least 2 times within 8 days after treatment
    enhanced_encryption
    Safety Issue:
    yes
  • Vital signs: Heart rate, blood pressure
    date_rangeTime Frame:
    at least 2 times within 8 days after treatment
    enhanced_encryption
    Safety Issue:
    yes
  • Adverse events collection
    date_rangeTime Frame:
    continuously for at least 8 days after treatment
    enhanced_encryption
    Safety Issue:
    yes

Trial design

Open-label, multicenter study for an evaluation of radiation dosimetry, metabolism, safety and tolerability of the [F18] labeled PET (positron emission tomography) tracer BAY 85-8050 following a single intravenous administration in healthy volunteers, as well as the investigation of safety, tolerability and diagnostic performance of the tracer in PET/CT (computer tomography) in patients
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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