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

This study has been terminated.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00975299
First received: September 10, 2009
Last updated: June 27, 2013
Last verified: June 2013
  Purpose

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


Condition Intervention Phase
Diagnostic Imaging
Drug: BAY86-4367
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Visual assessment of lesions [ Time Frame: Day of study drug administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quantitative analysis of BAY86-4367 uptake into lesions (Standardized Uptake Values = SUVs) [ Time Frame: Day of study drug administration ] [ Designated as safety issue: No ]
  • Electrocardiogram (ECG) [ Time Frame: At least 3 times within 8 days after treatment ] [ Designated as safety issue: Yes ]
  • Blood pressure [ Time Frame: At least 3 times within 8 days after treatment ] [ Designated as safety issue: Yes ]
  • Serum protein [ Time Frame: At least 3 times within 8 days after treatment ] [ Designated as safety issue: Yes ]
  • Serum creatinine [ Time Frame: At least 3 times within 8 days after treatment ] [ Designated as safety issue: Yes ]
  • Serum GOT (Glutamat-Oxalacetat-Transaminase) [ Time Frame: At least 3 times within 8 days after treatment ] [ Designated as safety issue: Yes ]
  • Adverse events collection [ Time Frame: At least 3 times within 8 days after treatment ] [ Designated as safety issue: Yes ]

Enrollment: 16
Study Start Date: September 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: BAY86-4367
Cancer patients, single intravenous bolus injection of 300 MBq BAY86-4367 on day one of the treatment period, PET/CT
Experimental: Arm 2 Drug: 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

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00975299

Locations
Germany
München, Bayern, Germany, 81675
Switzerland
Zürich, Switzerland, 8091
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Head Clinical Pharmacology, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT00975299     History of Changes
Other Study ID Numbers: 13991, 2008-007460-42
Study First Received: September 10, 2009
Last Updated: June 27, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Switzerland: Swissmedic

Keywords provided by Bayer:
Neoplasm
PET/CT diagnosis
PET tracer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 16, 2014