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

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

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
• Actual Primary Completion Date: September 2011
• Actual Study Completion Date: September 2011

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

• Ages Eligible for Study: 30 Years to 80 Years (Adult, Older Adult)
• 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

Locations

Netherlands

Groningen, Netherlands, 9713 GZ

Switzerland

Zürich, Switzerland, 8091

Sponsors and Collaborators

Life Molecular Imaging SA

Investigators

• Study Director: Bayer Study Director; Bayer

More Information

• Responsible Party: Life Molecular Imaging SA
• ClinicalTrials.gov Identifier: NCT01089998
• Other Study ID Numbers: 14641; 2009-013098-16 ( EudraCT Number )
• First Posted: March 19, 2010
• Last Update Posted: January 21, 2013
• Last Verified: January 2013

Keywords provided by Life Molecular Imaging SA:

Neoplasm; PET/CT diagnosis; PET tracer; Inflammation

Additional relevant MeSH terms:

Head and Neck Neoplasms; Breast Neoplasms; Inflammation; Neoplasms by Site; Neoplasms; Pathologic Processes; Breast Diseases; Skin Diseases; Fluorodeoxyglucose F18; Radiopharmaceuticals; Molecular Mechanisms of Pharmacological Action