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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Piramal Imaging SA
ClinicalTrials.gov Identifier:
NCT01089998
First received: March 18, 2010
Last updated: January 18, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention Phase
Diagnostic Imaging
 Drug: BAY86-9596
Drug: Fludeoxyglucose (18F)-IBA
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Piramal Imaging SA:

Primary Outcome Measures:
  • Visual assessment of lesions (tumor detection rate of BAY 86-9596 compared to FDG) [ Time Frame: Day of study drug administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quantitative analysis of BAY 86-9596 uptake into lesions (Standardized Uptake Values = SUVs) [ Time Frame: Day of study drug administration ] [ Designated as safety issue: No ]
  • Vital signs (ECG, blood pressure, Heart rate, Body temperature) [ Time Frame: At least 2 times within 8 days after treatment ] [ Designated as safety issue: Yes ]
  • Serum chemistry, Clotting status, Hematology [ Time Frame: At least 2 times within 8 days after treatment ] [ Designated as safety issue: Yes ]
  • Adverse Event collection [ Time Frame: At least 2 times within 8 days after treatment ] [ Designated as safety issue: Yes ]

Enrollment: 35
Study Start Date: May 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Piramal Imaging SA
ClinicalTrials.gov Identifier: NCT01089998     History of Changes
Other Study ID Numbers: 14641, 2009-013098-16
Study First Received: March 18, 2010
Last Updated: January 18, 2013
Health Authority: Nederlands: CCMO=Centrale Commissie Mensgebonden Onderzoek (Central Committee on Research inv. Human Subjects)
Switzerland: Swissmedic (Schweizerisches Heilmittelinstitut)

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

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma, Non-Small-Cell Lung
Head and Neck Neoplasms
Inflammation
Lung Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
 Skin Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013