NCT01089998

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2010

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 19, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

January 21, 2013

Status Verified

January 1, 2013

Enrollment Period

1.3 years

First QC Date

March 18, 2010

Last Update Submit

January 18, 2013

Conditions

Diagnostic Imaging

Keywords

NeoplasmPET/CT diagnosisPET tracerInflammation

Outcome Measures

Primary Outcomes (1)

  • Visual assessment of lesions (tumor detection rate of BAY 86-9596 compared to FDG)

    Day of study drug administration

Secondary Outcomes (4)

  • 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

  • Serum chemistry, Clotting status, Hematology

    At least 2 times within 8 days after treatment

  • Adverse Event collection

    At least 2 times within 8 days after treatment

Study Arms (4)

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

BAY86-9596DRUG

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 1
Fludeoxyglucose (18F)-IBADRUG

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)

Arm 4

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • NSCLC (non small cell lung cancer), or
  • adenocarcinoma of the breast (female patients) or
  • squamous cell cancer of head and neck and the cancer disease is histologically confirmed.
  • Patients with confirmed/known inflammatory focus/foci after FDG-PET/CT imaging

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Groningen, Provincie Groningen, 9713 GZ, Netherlands

Location

Unknown Facility

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

NeoplasmsInflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2010

First Posted

March 19, 2010

Study Start

May 1, 2010

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

January 21, 2013

Record last verified: 2013-01

Locations

CH(1)NL(1)