ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00975299
Recruitment Status : Terminated
First Posted : September 11, 2009
Last Update Posted : June 26, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief 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

Condition or disease Intervention/treatment Phase
Diagnostic Imaging Drug: BAY86-4367 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : September 2009
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Visual assessment of lesions [ Time Frame: Day of study drug administration ]

Secondary Outcome Measures :
  1. Quantitative analysis of BAY86-4367 uptake into lesions (Standardized Uptake Values = SUVs) [ Time Frame: Day of study drug administration ]
  2. Electrocardiogram (ECG) [ Time Frame: At least 3 times within 8 days after treatment ]
  3. Blood pressure [ Time Frame: At least 3 times within 8 days after treatment ]
  4. Serum protein [ Time Frame: At least 3 times within 8 days after treatment ]
  5. Serum creatinine [ Time Frame: At least 3 times within 8 days after treatment ]
  6. Serum GOT (Glutamat-Oxalacetat-Transaminase) [ Time Frame: At least 3 times within 8 days after treatment ]
  7. Adverse events collection [ Time Frame: At least 3 times within 8 days after treatment ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00975299


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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00975299     History of Changes
Other Study ID Numbers: 13991
2008-007460-42 ( EudraCT Number )
First Posted: September 11, 2009    Key Record Dates
Last Update Posted: June 26, 2014
Last Verified: June 2014

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
Bombesin
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs