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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

September 17, 2010
January 18, 2013
November 2010
November 2011   (final data collection date for primary outcome measure)
Visual assessment of lesions [ Time Frame: Day of study drug administration ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01205321 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Diagnostic Imaging
  • 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
  • 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
  • Experimental: Arm 1
    Intervention: Drug: Bombesin (68Ga) labeled (BAY86-7548)
  • Experimental: Arm 2
    Intervention: Drug: Bombesin (68Ga) labeled (BAY86-7548)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
December 2011
November 2011   (final data collection date for primary outcome measure)

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.
Male
45 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Finland,   Germany,   Switzerland
 
NCT01205321
14269, 2008-008315-25
No
Piramal Imaging SA
Piramal Imaging SA
Not Provided
Study Director: Bayer Study Director Bayer
Piramal Imaging SA
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP