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
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: 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:
Inflammation
Neoplasms
Pathologic Processes

ClinicalTrials.gov processed this record on October 29, 2014