check_circleStudy Completed
Diagnostic Imaging
Bayer Identifier:
15146
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
BothAge
30 - 80 YearsTrial summary
Enrollment Goal
24Trial Dates
May 2011 - December 2011Phase
Phase 1Could I Receive a placebo
NoProducts
D-[F18]-Fluoromethyl tyrosine (BAY86-9596)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Singapore General Hospital | Singapore, 169608, Singapore |
Terminated | National University Hospital | Singapore, 119074, Singapore |
Primary Outcome
- BAY86-9596 lesion detection rate (overall number of lesions identified).date_rangeTime Frame:up to 2 hoursenhanced_encryptionNoSafety Issue:
- Overall image quality (poor, satisfactory, excellent; based on investigator’s experience with 18F-labeled PET tracers)date_rangeTime Frame:up to 2 hoursenhanced_encryptionNoSafety Issue:
- BAY86-9596 accumulation score in identified lesions (low accumulation, high accumulation).date_rangeTime Frame:up to 2 hoursenhanced_encryptionNoSafety Issue:
- 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 hoursenhanced_encryptionNoSafety Issue:
- Comparison of BAY86-9596 accumulation with lesions identified in histology of prostate cancer.date_rangeTime Frame:up to 2 hoursenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
DiagnosticAllocation
Non-randomizedBlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1