Positron Emission Tomography/Computed Tomography (PET/CT) Imaging for Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Tolerability and Diagnostic Performance of BAY86-4367 in Patients With Prostate Cancer and Healthy Volunteers

Diagnostic Imaging Clinical Trial

Official title:

Open-label, Multicenter PET/CT (Positron Emission Tomography/Computed Tomography) Study for Investigation of Safety, Tolerability, Biodistribution and Diagnostic Performance of the 18F Labeled PET Tracer BAY86-4367 Following a Single Intravenous Administration of 300 MBq (Corresponding to </= 40 µg Mass Dose) in Patients With Prostate Cancer as Well as Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Tolerability of the Tracer in PET/CT in Healthy Volunteers

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00975299
• Other study ID #: 13991
• Secondary ID: 2008-007460-42
• Status: Terminated
• Phase: Phase 1
• First received: September 10, 2009
• Last updated: June 25, 2014
• Start date: September 2009
• Est. completion date: October 2010

Study information

• Verified date: June 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesSwitzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

Visual assessment of diagnostic PET/CT (positron emission tomography/computed tomography) images obtained after a single intravenous injection of BAY86-4367 in patients with cancer

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• Healthy volunteers:

• males, >/=50 and <= 65 years of age

• Cancer patients:

• males >/= 45 years of age

• patients with recurrent prostate cancer had a positive choline PET/CT for detection, or staging, or restaging of cancer, evaluation of the primary prostate cancer detection rate with BAY 86-4367 in comparison to histology as standard of truth (choline PET/CT is optional).

Exclusion Criteria:

• Exclusion criteria for all healthy volunteers and patients:

• 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 BAY 86-4367, 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diagnostic Imaging

Intervention

Drug:
• BAY86-4367
Cancer patients, single intravenous bolus injection of 300 MBq BAY86-4367 on day one of the treatment period, PET/CT
• BAY86-4367
Healthy volunteers, single intravenous bolus injection of 300 MBq BAY86-4367 on day one of the treatment period, whole body PET/CT for determination of effective dose., kinetics of BAY86-4367 in blood

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual assessment of lesions		Day of study drug administration	No
Secondary	Quantitative analysis of BAY86-4367 uptake into lesions (Standardized Uptake Values = SUVs)		Day of study drug administration	No
Secondary	Electrocardiogram (ECG)		At least 3 times within 8 days after treatment	Yes
Secondary	Blood pressure		At least 3 times within 8 days after treatment	Yes
Secondary	Serum protein		At least 3 times within 8 days after treatment	Yes
Secondary	Serum creatinine		At least 3 times within 8 days after treatment	Yes
Secondary	Serum GOT (Glutamat-Oxalacetat-Transaminase)		At least 3 times within 8 days after treatment	Yes
Secondary	Adverse events collection		At least 3 times within 8 days after treatment	Yes

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