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

NCT ID: NCT01089998

Last Updated: 2013-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2011-09-30

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

Conditions

Diagnostic Imaging

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Arm 1

Group Type: EXPERIMENTAL

BAY86-9596

Intervention Type: DRUG

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

Arm 2

Group Type: EXPERIMENTAL

BAY86-9596

Intervention Type: DRUG

Cancer patients, single intravenous bolus injection of 300 MBq BAY 86-9596 on day one of the treatment period, PET/CT.

Arm 3

Group Type: EXPERIMENTAL

BAY86-9596

Intervention Type: DRUG

Inflammation patients, single intravenous bolus injection of 300 MBq BAY 86-9596 on day one of the treatment period, PET/CT.

Arm 4

Group Type: EXPERIMENTAL

Fludeoxyglucose (18F)-IBA

Intervention Type: DRUG

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)

Interventions

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

Intervention Type: DRUG

BAY86-9596

Cancer patients, single intravenous bolus injection of 300 MBq BAY 86-9596 on day one of the treatment period, PET/CT.

Intervention Type: DRUG

BAY86-9596

Inflammation patients, single intravenous bolus injection of 300 MBq BAY 86-9596 on day one of the treatment period, PET/CT.

Intervention Type: 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)

Intervention Type: DRUG

Eligibility 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

• 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Life Molecular Imaging SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Groningen, Provincie Groningen, Netherlands

Zurich, Canton of Zurich, Switzerland

Countries

Netherlands; Switzerland

Other Identifiers

2009-013098-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

14641

Identifier Type: -

Identifier Source: org_study_id