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
  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:


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
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:
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:
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
Pharmacologic Actions
Physiological Effects of Drugs
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014