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PET/CT Imaging for Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Tolerability and Diagnostic Performance of BAY86-7548 in Patients With Prostate Cancer and Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Piramal Imaging SA
ClinicalTrials.gov Identifier:
NCT01205321
First received: September 17, 2010
Last updated: January 18, 2013
Last verified: January 2013
History of Changes
  Purpose

Visual assessment of diagnostic PET/CT (positron emission tomography/computed tomography) images obtained after a single intravenous injection of BAY86-7548 in patients with cancer.


Condition Intervention Phase
Diagnostic Imaging
 Drug: Bombesin (68Ga) labeled (BAY86-7548)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Open-label, Multi Center PET/CT (Positron Emission Tomography/Computed Tomography) Study for Investigation of Safety, Tolerability, Biodistribution and Diagnostic Performance of the 68Ga Labeled PET Tracer BAY86-7548 Following a Single Intravenous Administration of 140 MBq (Corresponding to ≤ 28 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:

U.S. FDA Resources

Further study details as provided by Piramal Imaging SA:

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 BAY86-7548 uptake into lesions (Standardized Uptake Values = SUVs) [ Time Frame: Day of study drug administration ] [ Designated as safety issue: No ]
  • ECG (significant abnormalities) [ Time Frame: At least 3 times until one day after treatment ] [ Designated as safety issue: Yes ]
  • Blood pressure [ Time Frame: At least 3 times until one day after treatment ] [ Designated as safety issue: Yes ]
  • Serum protein [ Time Frame: At least 3 times until one day after treatment ] [ Designated as safety issue: Yes ]
  • Serum creatinine [ Time Frame: At least 3 times until one day after treatment ] [ Designated as safety issue: Yes ]
  • Serum GOT (Glutamat-Oxalacetat-Transaminase) [ Time Frame: At least 3 times until one day after treatment ] [ Designated as safety issue: Yes ]
  • Adverse events collection [ Time Frame: Continuously for at least 5 days after treatment ] [ Designated as safety issue: Yes ]
Enrollment: 19
Study Start Date: November 2010
Study Completion Date: December 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Bombesin (68Ga) labeled (BAY86-7548)
Cancer patients, single intravenous bolus injection of 140 MBq BAY86-7548 on day one of the treatment period, PET/CT
Experimental: Arm 2 Drug: Bombesin (68Ga) labeled (BAY86-7548)
Healthy volunteers, single intravenous bolus injection of 140 MBq BAY86-7548 on day one of the treatment period, whole body PET/CT for determination of effective dose, kinetics of BAY86-7548 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 had an MRI of the prostate and/or a positive choline or acetate PET/CT for diagnosis (Note: MRI, choline and acetate PET/CT are optional for primary prostate cancer patients) of recurrence prostate cancer and the primary cancer disease is/ will be histologically confirmed.
    • The prostate cancer is histologically confirmed and results of histology are available.
    • Patients with primary prostate cancer: >/= 20 percent of biopsy material should be affected by cancer in the histopathological evaluation.
    • Patients with primary prostate cancer: Patient is scheduled to undergo prostatectomy.

Exclusion Criteria:

  • 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 BAY86-7548, 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01205321

Locations
Finland
Turku, Finland, FIN-20521
Germany
Ulm, Baden-Württemberg, Germany, 89081
Switzerland
Zürich, Switzerland, 8091
Sponsors and Collaborators
Piramal Imaging SA
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Piramal Imaging SA
ClinicalTrials.gov Identifier: NCT01205321     History of Changes
Other Study ID Numbers: 14269, 2008-008315-25
Study First Received: September 17, 2010
Last Updated: January 18, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Finland: Finnish Medicines Agency
Switzerland: Swissmedic

Keywords provided by Piramal Imaging SA:
Neoplasm
PET/CT diagnosis
PET tracer

Additional relevant MeSH terms:
Bombesin
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 27, 2015