Radiation Dosimetry, Metabolism, Pharmacokinetics, Safety and Tolerability and PET Imaging With BAY94-9392 in Healthy Volunteers and Patients With Cancer or Inflammation

November 11, 2014 updated by: Life Molecular Imaging SA

Open-label, Multi Center Study for an Evaluation of Radiation Dosimetry, Plasma Pharmacokinetics, Safety and Tolerability of the 18F-labeled PET/CT (Positron Emission Tomography / Computed Tomography) Tracer BAY94-9392 Following a Single Intravenous Administration of 300 MBq (Corresponding to ≤ 100 µg Total Quantity) in Healthy Volunteers, as Well as the Investigation of Safety, Tolerability, Pharmacokinetics, and Diagnostic Performance of the Tracer in PET/CT in Cancer Patients or Patients With Inflammation.

Visual assessment of diagnostic PET/CT (positron emission tomography/computed tomography) images obtained after a single intravenous injection of BAY94-9392 in patients with cancer or inflammation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion criteria:

In Germany Healthy volunteers

  • Males/females ≥ 50 and ≤ 65 years Patients
  • Males/females ≥ 35 and ≤ 75 years
  • histologically confirmed diagnosis of non small cell lung cancer or adenocarcinoma of the breast with a positive FDG-PET or
  • patient with primary prostate cancer scheduled for prostatectomy and patient with prostate tumor recurrence with a positive choline-PET, the initial disease is histologically confirmed or
  • inflammation with a positive FDG-PET

In Korea Patients

  • Males/females ≥ 35 and ≤ 75 years
  • histologically confirmed diagnosis of non small cell lung cancer, adenocarcinoma of the breast or hepatocellular cancer with a positive FDG-PET or
  • patient with primary prostate cancer scheduled for prostatectomy and patient with prostate tumor recurrence with a positive choline-PET, the initial disease is histologically confirmed or
  • inflammation (positive FDG-PET mandatory, could be also done as screening examination)

Exclusion criteria:

  • Concurrent severe and/or uncontrolled and/or unstable medical disease other than cancer or inflammation (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 12 months prior to planned injection of BAY 94-9392, unstable and uncontrolled hypertension, chronic renal or hepatic disease, severe pulmonary disease) which could compromise participation in the study
  • Known sensitivity to the study drug or components of the preparation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Cancer patients, single intravenous bolus injection of 300 MBq BAY94-9392 on day one of the treatment period, PET/CT
Drug: BAY94-9392
Experimental: Arm 2
Healthy volunteers, single intravenous bolus injection of 300 MBq BAY94-9392 on day one of the treatment period, whole body PET/CT for determination of effective dose, kinetics of BAY94-9392 in blood
Drug: BAY94-9392

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visual assessment of lesion
Time Frame: Day of study drug administration
Day of study drug administration

Secondary Outcome Measures

Outcome Measure
Time Frame
Quantitative analysis of BAY94-9392 uptake into lesions (Standardized Uptake Values = SUVs)
Time Frame: Day of study drug administration
Day of study drug administration
Electrocardiogram (ECG)
Time Frame: At least twice within 2 days after treatment
At least twice within 2 days after treatment
Blood pressure
Time Frame: At least twice within 2 days after treatment
At least twice within 2 days after treatment
Serum protein
Time Frame: At least twice within 2 days after treatment
At least twice within 2 days after treatment
Serum creatinine
Time Frame: At least twice within 2 days after treatment
At least twice within 2 days after treatment
Serum GOT (Glutamate-Oxalacetate-Transaminase)
Time Frame: At least twice within 2 days after treatment
At least twice within 2 days after treatment
Adverse events collection
Time Frame: Continuously for at least 4 days after treatment
Continuously for at least 4 days after treatment
Radiation doses per organ (µGy/MBq)
Time Frame: Day of study drug administration
Day of study drug administration
Higher organ dose (HT)
Time Frame: Day of study drug administration
Day of study drug administration
Doses per organ (µSv/MBq)
Time Frame: Day of study drug administration
Day of study drug administration
Effective dose (µSv/MBq)
Time Frame: Day of study drug administration
Day of study drug administration
Effective dose resulting from the total administered diagnostic activity of 300 MBq +/- 10%
Time Frame: Day of study drug administration
Day of study drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Life Molecular Imaging SA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

March 31, 2010

First Submitted That Met QC Criteria

April 13, 2010

First Posted (Estimate)

April 14, 2010

Study Record Updates

Last Update Posted (Estimate)

November 13, 2014

Last Update Submitted That Met QC Criteria

November 11, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14207

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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