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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

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ClinicalTrials.gov Identifier: NCT01205321
Recruitment Status : Completed
First Posted : September 20, 2010
Last Update Posted : January 21, 2013
Sponsor:
Information provided by (Responsible Party):
Piramal Imaging SA

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Diagnostic Imaging Drug: Bombesin (68Ga) labeled (BAY86-7548) Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 2010
Actual Primary Completion Date : November 2011
Actual Study Completion Date : December 2011

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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


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

Secondary Outcome Measures :
  1. Quantitative analysis of BAY86-7548 uptake into lesions (Standardized Uptake Values = SUVs) [ Time Frame: Day of study drug administration ]
  2. ECG (significant abnormalities) [ Time Frame: At least 3 times until one day after treatment ]
  3. Blood pressure [ Time Frame: At least 3 times until one day after treatment ]
  4. Serum protein [ Time Frame: At least 3 times until one day after treatment ]
  5. Serum creatinine [ Time Frame: At least 3 times until one day after treatment ]
  6. Serum GOT (Glutamat-Oxalacetat-Transaminase) [ Time Frame: At least 3 times until one day after treatment ]
  7. Adverse events collection [ Time Frame: Continuously for at least 5 days after treatment ]

Eligibility Criteria
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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 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
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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): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
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Responsible Party: Piramal Imaging SA
ClinicalTrials.gov Identifier: NCT01205321     History of Changes
Other Study ID Numbers: 14269
2008-008315-25 ( EudraCT Number )
First Posted: September 20, 2010    Key Record Dates
Last Update Posted: January 21, 2013
Last Verified: January 2013

Keywords provided by Piramal Imaging SA:
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
Gastrin-Releasing Peptide
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Gastrointestinal Agents