check_circleStudy Completed

Diagnostic Imaging

PET/CT (positron emission tomography / computed tomography) investigations with BAY86-9596 (18F) (300 MBq) following single intravenous administration in patients with cancer or inflammations.

Trial purpose

The study will be conducted as an open label, single-center, single dose and biodistribution study in patients with cancer or inflammation. 56 patients will be selected among the patients undergoing the screening examination conducted within 3 weeks before drug administration. Single dose of the study drug will be administrated in a dose of 300 MBq to these patients. The follow-up period contains the end-of-study telephone interview 5-8 days following the treatment. Key measurements are the PET/CT image acquisitions within a time frame of about 2 hours after the single injection of BAY86-9596.

Key Participants Requirements

Sex

Both

Age

30 - 80 Years

Trial summary

Enrollment Goal
24
Trial Dates
May 2011 - December 2011
Phase
Phase 1
Could I Receive a placebo
No
Products
D-[F18]-Fluoromethyl tyrosine (BAY86-9596)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Singapore General HospitalSingapore, 169608, Singapore
Terminated
National University HospitalSingapore, 119074, Singapore

Primary Outcome

  • BAY86-9596 lesion detection rate (overall number of lesions identified).
    date_rangeTime Frame:
    up to 2 hours
    enhanced_encryption
    Safety Issue:
    No
  • Overall image quality (poor, satisfactory, excellent; based on investigator’s experience with 18F-labeled PET tracers)
    date_rangeTime Frame:
    up to 2 hours
    enhanced_encryption
    Safety Issue:
    No
  • BAY86-9596 accumulation score in identified lesions (low accumulation, high accumulation).
    date_rangeTime Frame:
    up to 2 hours
    enhanced_encryption
    Safety Issue:
    No
  • Comparative score BAY86-9596 versus FDG. If an FDG PET/CT is not available (in malignant brain tumors or in brain metastasis), this comparison will be done with routine imaging modalities such as CT or MRI, or choline PET/CT.
    date_rangeTime Frame:
    up to 2 hours
    enhanced_encryption
    Safety Issue:
    No
  • Comparison of BAY86-9596 accumulation with lesions identified in histology of prostate cancer.
    date_rangeTime Frame:
    up to 2 hours
    enhanced_encryption
    Safety Issue:
    No

Trial design

Open-label, single center study of the 18F-labeled PET/CT (positron emission tomography / computed tomography) tracer BAY86-9596 following a single intravenous administration of 300 MBq (corresponding to ≤ 18 µg mass dose) for evaluation of biodistribution in pathological tissue in patients with cancer or inflammation
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Diagnostic
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1