PET/CT Imaging for Radiation Dosimetry, Plasma Pharmacoki... | NCT01089998

Studies
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

NCT01089998

Sponsor

Lantheus Biosciences Ltd.

Status

Completed

Last Update Posted

Jan 21, 2013Estimated

Enrollment

35Actual

Phase

Phase 1

Conditions

Diagnostic Imaging

Interventions

BAY86-9596
BAY86-9596
BAY86-9596
Fludeoxyglucose (18F)-IBA

Countries

Netherlands
Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
2009-013098-16	EudraCT Number

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.

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2010

Primary Completion Date

Sep 2011Actual

Completion Date

Sep 2011Actual

First Submitted Date

Mar 18, 2010

First Submission Date that Met QC Criteria

Mar 18, 2010

First Posted Date

Mar 19, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 18, 2013

Last Update Posted Date

Jan 21, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Arm 1	Experimental	Drug: BAY86-9596
Arm 2	Experimental	Drug: BAY86-9596
Arm 3	Experimental	Drug: BAY86-9596
Arm 4	Experimental	Drug: Fludeoxyglucose (18F)-IBA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BAY86-9596	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual assessment of lesions (tumor detection rate of BAY 86-9596 compared to FDG)		Day of study drug administration

Secondary Outcomes

Measure	Description	Time Frame
Quantitative analysis of BAY 86-9596 uptake into lesions (Standardized Uptake Values = SUVs)		Day of study drug administration
Vital signs (ECG, blood pressure, Heart rate, Body temperature)		At least 2 times within 8 days after treatment

Other Outcomes

Not provided

Eligibility Module

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:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Groningen	Provincie Groningen	9713 GZ	Netherlands

ID	Term
D009369	Neoplasms
D007249	Inflammation

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms