Radiation Dosimetry, Metabolism, Pharmacokinetics, Safety and Tolerability and PET Imaging With BAY94-9392 in Healthy Volunteers and Patients With Cancer or Inflammation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Piramal Imaging SA
ClinicalTrials.gov Identifier:
NCT01103310
First received: March 31, 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 BAY94-9392 in patients with cancer or inflammation.


Condition Intervention Phase
Diagnostic Imaging
Neoplasms
Drug: BAY94-9392
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Open-label, Multi Center Study for an Evaluation of Radiation Dosimetry, Plasma Pharmacokinetics, Safety and Tolerability of the 18F-labeled PET/CT (Positron Emission Tomography / Computed Tomography) Tracer BAY94-9392 Following a Single Intravenous Administration of 300 MBq (Corresponding to ≤ 100 µg Total Quantity) in Healthy Volunteers, as Well as the Investigation of Safety, Tolerability, Pharmacokinetics, and Diagnostic Performance of the Tracer in PET/CT in Cancer Patients or Patients With Inflammation.

Resource links provided by NLM:


Further study details as provided by Piramal Imaging SA:

Primary Outcome Measures:
  • Visual assessment of lesion [ Time Frame: Day of study drug administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quantitative analysis of BAY94-9392 uptake into lesions (Standardized Uptake Values = SUVs) [ Time Frame: Day of study drug administration ] [ Designated as safety issue: No ]
  • Electrocardiogram (ECG) [ Time Frame: At least twice within 2 days after treatment ] [ Designated as safety issue: Yes ]
  • Blood pressure [ Time Frame: At least twice within 2 days after treatment ] [ Designated as safety issue: Yes ]
  • Serum protein [ Time Frame: At least twice within 2 days after treatment ] [ Designated as safety issue: Yes ]
  • Serum creatinine [ Time Frame: At least twice within 2 days after treatment ] [ Designated as safety issue: Yes ]
  • Serum GOT (Glutamate-Oxalacetate-Transaminase) [ Time Frame: At least twice within 2 days after treatment ] [ Designated as safety issue: Yes ]
  • Adverse events collection [ Time Frame: Continuously for at least 4 days after treatment ] [ Designated as safety issue: Yes ]

Enrollment: 46
Study Start Date: April 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Cancer patients, single intravenous bolus injection of 300 MBq BAY94-9392 on day one of the treatment period, PET/CT
Drug: BAY94-9392
Experimental: Arm 2
Healthy volunteers, single intravenous bolus injection of 300 MBq BAY94-9392 on day one of the treatment period, whole body PET/CT for determination of effective dose, kinetics of BAY94-9392 in blood
Drug: BAY94-9392

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

In Germany Healthy volunteers

  • Males/females ≥ 50 and ≤ 65 years Patients
  • Males/females ≥ 35 and ≤ 75 years
  • histologically confirmed diagnosis of non small cell lung cancer or adenocarcinoma of the breast with a positive FDG-PET or
  • patient with primary prostate cancer scheduled for prostatectomy and patient with prostate tumor recurrence with a positive choline-PET, the initial disease is histologically confirmed or
  • inflammation with a positive FDG-PET

In Korea Patients

  • Males/females ≥ 35 and ≤ 75 years
  • histologically confirmed diagnosis of non small cell lung cancer, adenocarcinoma of the breast or hepatocellular cancer with a positive FDG-PET or
  • patient with primary prostate cancer scheduled for prostatectomy and patient with prostate tumor recurrence with a positive choline-PET, the initial disease is histologically confirmed or
  • inflammation (positive FDG-PET mandatory, could be also done as screening examination)

Exclusion criteria:

  • Concurrent severe and/or uncontrolled and/or unstable medical disease other than cancer or inflammation (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 12 months prior to planned injection of BAY 94-9392, 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: NCT01103310

Locations
United States, California
Stanford, California, United States, 94305
Germany
München, Bayern, Germany, 81675
Korea, Republic of
Seoul, Korea, Republic of, 138-736
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: NCT01103310     History of Changes
Other Study ID Numbers: 14207, 2008-008316-15
Study First Received: March 31, 2010
Last Updated: January 18, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Korea: Food and Drug Administration

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

Additional relevant MeSH terms:
Neoplasms
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014