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PET/CT Imaging for Radiation Dosimetry, Plasma Pharmacokinetics, Safety and Tolerability in Healthy Volunteers and Safety, Tolerability and Diagnostic Performance of BAY86-9596 in Patients With Non-small Cell Lung Cancer, Breast Cancer, Head and Neck Cancer and Patients With Inflammations

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ClinicalTrials.gov Identifier: NCT01089998
Recruitment Status : Completed
First Posted : March 19, 2010
Last Update Posted : January 21, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Visual assessment of diagnostic PET/CT (positron emission tomography/computed tomography) images obtained after a single intravenous injection of BAY86-9596 in patients with cancer and inflammation

Condition or disease Intervention/treatment Phase
Diagnostic Imaging Drug: BAY86-9596 Drug: Fludeoxyglucose (18F)-IBA Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Open-label, Multicenter Study of the 18F-labeled PET/CT (Positron Emission Tomography / Computed Tomography) Tracer BAY86-9596 Following a Single Intravenous Administration of 200 or 300 MBq (Corresponding to ≤ 18 µg Mass Dose) for Evaluation of Radiation Dosimetry, Plasma Pharmacokinetics, Safety and Tolerability in Healthy Volunteers (200 MBq) as Well as Investigation of Safety, Tolerability and Diagnostic Performance in Patients (300 MBq) With Non-small Cell Lung Cancer, Breast Cancer, Head and Neck Cancer and in Patients With Inflammation.
Study Start Date : May 2010
Primary Completion Date : September 2011
Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Arm 1 Drug: BAY86-9596
Healthy volunteers, single intravenous bolus injection of 200 MBq BAY 86-9596 on day one of the treatment period, whole body PET/CT for determination of effective dose, kinetics of BAY 86-9596 in blood and urine
Experimental: Arm 2 Drug: BAY86-9596
Cancer patients, single intravenous bolus injection of 300 MBq BAY 86-9596 on day one of the treatment period, PET/CT.
Experimental: Arm 3 Drug: BAY86-9596
Inflammation patients, single intravenous bolus injection of 300 MBq BAY 86-9596 on day one of the treatment period, PET/CT.
Experimental: Arm 4 Drug: Fludeoxyglucose (18F)-IBA
Subgroup of cancer patients: radiation induced inflammation. Fluordeoxyglucose (18F)-FDG PET scan will be performed approx. 4 week after radiation and compared with tracer BAY86-9596 (acc. to Amendment 4 only in the Netherlands)


Outcome Measures

Primary Outcome Measures :
  1. Visual assessment of lesions (tumor detection rate of BAY 86-9596 compared to FDG) [ Time Frame: Day of study drug administration ]

Secondary Outcome Measures :
  1. Quantitative analysis of BAY 86-9596 uptake into lesions (Standardized Uptake Values = SUVs) [ Time Frame: Day of study drug administration ]
  2. Vital signs (ECG, blood pressure, Heart rate, Body temperature) [ Time Frame: At least 2 times within 8 days after treatment ]
  3. Serum chemistry, Clotting status, Hematology [ Time Frame: At least 2 times within 8 days after treatment ]
  4. Adverse Event collection [ Time Frame: At least 2 times within 8 days after treatment ]

Eligibility Criteria

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers only

    • Males/females ≥ 50 years and ≤ 65 years of age
  • Cancer patients and inflammation patients (inflammation patients in study part 2 = optional, in study part 3 mandatory)

    • Males/females ≥ 30 and ≤ 80 years of age
    • patients had an FDG PET/CT for detection, or staging, or restaging, or therapy response assessment that still showed tumor mass with high certainty, for

      1. NSCLC (non small cell lung cancer), or
      2. adenocarcinoma of the breast (female patients) or
      3. squamous cell cancer of head and neck and the cancer disease is histologically confirmed.
      4. Patients with confirmed/known inflammatory focus/foci after FDG-PET/CT imaging

Exclusion Criteria:

  • Exclusion criteria for all healthy volunteers and patients:

    • any concomitant disease (for healthy volunteers) and for patients any 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 BAY86-9596, unstable and uncontrolled hypertension, chronic renal or hepatic disease, severe pulmonary disease) which could compromise participation in the study
    • For healthy volunteers and patients: known sensitivity to the study drug or components of the preparation.
    • tumor patients with known inflammatory disease, where images overlap inflammatory lesions with tumor lesions
Contacts and Locations

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): NCT01089998


Locations
Netherlands
Groningen, Netherlands, 9713 GZ
Switzerland
Zürich, Switzerland, 8091
Sponsors and Collaborators
Piramal Imaging SA
Investigators
Study Director: Bayer Study Director Bayer
More Information

Additional Information:
Responsible Party: Piramal Imaging SA
ClinicalTrials.gov Identifier: NCT01089998     History of Changes
Other Study ID Numbers: 14641
2009-013098-16 ( EudraCT Number )
First Posted: March 19, 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
Inflammation

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Inflammation
Head and Neck Neoplasms
Breast Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Pathologic Processes
Breast Diseases
Skin Diseases
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action