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

Diagnostic Imaging Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01089998
• Other study ID #: 14641
• Secondary ID: 2009-013098-16
• Status: Completed
• Phase: Phase 1
• First received: March 18, 2010
• Last updated: January 18, 2013
• Start date: May 2010
• Est. completion date: September 2011

Study information

• Verified date: January 2013
• Source: Piramal Imaging SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Nederlands: CCMO=Centrale Commissie Mensgebonden Onderzoek (Central Committee on Research inv. Human Subjects)Switzerland: Swissmedic (Schweizerisches Heilmittelinstitut)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Neoplasms
• Carcinoma, Non-Small-Cell Lung
• Diagnostic Imaging
• Head and Neck Neoplasms
• Inflammation

Intervention

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
• BAY86-9596
Cancer patients, single intravenous bolus injection of 300 MBq BAY 86-9596 on day one of the treatment period, PET/CT.
• BAY86-9596
Inflammation patients, single intravenous bolus injection of 300 MBq BAY 86-9596 on day one of the treatment period, PET/CT.
• 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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Piramal Imaging SA

Countries where clinical trial is conducted

Netherlands,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual assessment of lesions (tumor detection rate of BAY 86-9596 compared to FDG)		Day of study drug administration	No
Secondary	Quantitative analysis of BAY 86-9596 uptake into lesions (Standardized Uptake Values = SUVs)		Day of study drug administration	No
Secondary	Vital signs (ECG, blood pressure, Heart rate, Body temperature)		At least 2 times within 8 days after treatment	Yes
Secondary	Serum chemistry, Clotting status, Hematology		At least 2 times within 8 days after treatment	Yes
Secondary	Adverse Event collection		At least 2 times within 8 days after treatment	Yes

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