Back to resultsPET/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
Primary Purpose
Diagnostic Imaging
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
BAY86-9596
BAY86-9596
BAY86-9596
Fludeoxyglucose (18F)-IBA
Sponsored by
About this trial
This is an interventional diagnostic trial for Diagnostic Imaging focused on measuring Neoplasm, PET/CT diagnosis, PET tracer, Inflammation
Eligibility Criteria
Inclusion Criteria:
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
- NSCLC (non small cell lung cancer), or
- adenocarcinoma of the breast (female patients) or
- squamous cell cancer of head and neck and the cancer disease is histologically confirmed.
- Patients with confirmed/known inflammatory focus/foci after FDG-PET/CT imaging
Exclusion Criteria:
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Arm 1
Arm 2
Arm 3
Arm 4
Arm Description
Outcomes
Primary Outcome Measures
Visual assessment of lesions (tumor detection rate of BAY 86-9596 compared to FDG)
Secondary Outcome Measures
Quantitative analysis of BAY 86-9596 uptake into lesions (Standardized Uptake Values = SUVs)
Vital signs (ECG, blood pressure, Heart rate, Body temperature)
Serum chemistry, Clotting status, Hematology
Adverse Event collection
Full Information
NCT ID
NCT01089998
First Posted
March 18, 2010
Last Updated
January 18, 2013
Sponsor
Life Molecular Imaging SA
1. Study Identification
Unique Protocol Identification Number
NCT01089998
Brief Title
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
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Life Molecular Imaging SA
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diagnostic Imaging
Keywords
Neoplasm, PET/CT diagnosis, PET tracer, Inflammation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Experimental
Arm Title
Arm 3
Arm Type
Experimental
Arm Title
Arm 4
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
BAY86-9596
Intervention Description
Healthy volunteers, single intravenous bolus injection of 200 MBq BAY 86-9596 on day one of the treatment period, whole body PET/CT for determination of effective dose, kinetics of BAY 86-9596 in blood and urine
Intervention Type
Drug
Intervention Name(s)
BAY86-9596
Intervention Description
Cancer patients, single intravenous bolus injection of 300 MBq BAY 86-9596 on day one of the treatment period, PET/CT.
Intervention Type
Drug
Intervention Name(s)
BAY86-9596
Intervention Description
Inflammation patients, single intravenous bolus injection of 300 MBq BAY 86-9596 on day one of the treatment period, PET/CT.
Intervention Type
Drug
Intervention Name(s)
Fludeoxyglucose (18F)-IBA
Intervention Description
Subgroup of cancer patients: radiation induced inflammation. Fluordeoxyglucose (18F)-FDG PET scan will be performed approx. 4 week after radiation and compared with tracer BAY86-9596 (acc. to Amendment 4 only in the Netherlands)
Primary Outcome Measure Information:
Title
Visual assessment of lesions (tumor detection rate of BAY 86-9596 compared to FDG)
Time Frame
Day of study drug administration
Secondary Outcome Measure Information:
Title
Quantitative analysis of BAY 86-9596 uptake into lesions (Standardized Uptake Values = SUVs)
Time Frame
Day of study drug administration
Title
Vital signs (ECG, blood pressure, Heart rate, Body temperature)
Time Frame
At least 2 times within 8 days after treatment
Title
Serum chemistry, Clotting status, Hematology
Time Frame
At least 2 times within 8 days after treatment
Title
Adverse Event collection
Time Frame
At least 2 times within 8 days after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
NSCLC (non small cell lung cancer), or
adenocarcinoma of the breast (female patients) or
squamous cell cancer of head and neck and the cancer disease is histologically confirmed.
Patients with confirmed/known inflammatory focus/foci after FDG-PET/CT imaging
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
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
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