Radiation Dosimetry, Metabolism, Pharmacokinetics, Safety and Tolerability and PET Imaging With BAY94-9392 in Healthy Volunteers and Patients With Cancer or Inflammation

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01103310
• Date of registration: 31/03/2010
• Prospective Registration: Yes
• Primary sponsor: Piramal Imaging SA
• Public title: Radiation Dosimetry, Metabolism, Pharmacokinetics, Safety and Tolerability and PET Imaging With BAY94-9392 in Healthy Volunteers and Patients With Cancer or Inflammation
• Scientific title: Open-label, Multi Center Study for an Evaluation of Radiation Dosimetry, Plasma Pharmacokinetics, Safety and Tolerability of the 18F-labeled PET/CT (Positron Emission Tomography / Computed Tomography) Tracer BAY94-9392 Following a Single Intravenous Administration of 300 MBq (Corresponding to = 100 µg Total Quantity) in Healthy Volunteers, as Well as the Investigation of Safety, Tolerability, Pharmacokinetics, and Diagnostic Performance of the Tracer in PET/CT in Cancer Patients or Patients With Inflammation.
• Date of first enrolment: April 2010
• Target sample size: 46
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01103310
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
• Phase: Phase 1

Countries of recruitment

Germany, Korea, Republic of, United States

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion criteria

Inclusion criteria:

In Germany Healthy volunteers

- Males/females = 50 and = 65 years Patients

- Males/females = 35 and = 75 years

- histologically confirmed diagnosis of non small cell lung cancer or adenocarcinoma of
the breast with a positive FDG-PET or

- patient with primary prostate cancer scheduled for prostatectomy and patient with
prostate tumor recurrence with a positive choline-PET, the initial disease is
histologically confirmed or

- inflammation with a positive FDG-PET

In Korea Patients

- Males/females = 35 and = 75 years

- histologically confirmed diagnosis of non small cell lung cancer, adenocarcinoma of
the breast or hepatocellular cancer with a positive FDG-PET or

- patient with primary prostate cancer scheduled for prostatectomy and patient with
prostate tumor recurrence with a positive choline-PET, the initial disease is
histologically confirmed or

- inflammation (positive FDG-PET mandatory, could be also done as screening
examination)

Exclusion criteria:

- Concurrent severe and/or uncontrolled and/or unstable medical disease other than
cancer or inflammation (e.g. poorly controlled diabetes, congestive heart failure,
myocardial infarction within 12 months prior to planned injection of BAY 94-9392,
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



Age minimum: 35 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Diagnostic Imaging

Neoplasms

Intervention(s)

Drug: BAY94-9392

Primary Outcome(s)

Visual assessment of lesion [Time Frame: Day of study drug administration]

Secondary Outcome(s)

Effective dose resulting from the total administered diagnostic activity of 300 MBq +/- 10% [Time Frame: Day of study drug administration]

Quantitative analysis of BAY94-9392 uptake into lesions (Standardized Uptake Values = SUVs) [Time Frame: Day of study drug administration]

Serum creatinine [Time Frame: At least twice within 2 days after treatment]

Serum GOT (Glutamate-Oxalacetate-Transaminase) [Time Frame: At least twice within 2 days after treatment]

Adverse events collection [Time Frame: Continuously for at least 4 days after treatment]

Electrocardiogram (ECG) [Time Frame: At least twice within 2 days after treatment]

Serum protein [Time Frame: At least twice within 2 days after treatment]

Effective dose (µSv/MBq) [Time Frame: Day of study drug administration]

Radiation doses per organ (µGy/MBq) [Time Frame: Day of study drug administration]

Blood pressure [Time Frame: At least twice within 2 days after treatment]

Doses per organ (µSv/MBq) [Time Frame: Day of study drug administration]

Higher organ dose (HT) [Time Frame: Day of study drug administration]

Secondary ID(s)

14207

Source(s) of Monetary Support

Please refer to primary and secondary sponsors