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Completed

NCT Number: NCT00961831

Radiation Dosimetry, Metabolism, Safety, Tolerability and Positron Emission Tomography/Computed Tomography (PET/CT) Imaging With BAY 85-8050 in Healthy Volunteers and Patients

This study is a visual assessment of diagnostic PET/CT images obtained after a single intravenous injection of BAY85-8050 in patients with cancer

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Key information

Conditions

Neoplasm Neoplasms

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

München, Bavaria, 81675, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy volunteers only
  • Males/females, >/=50 and </= 65 years of age
  • Cancer patients only
  • Males/females >/= 35 years and </= 75 years of age
  • Patient had an FDG PET/CT for detection, or staging, or restaging, or therapy response assessment that still showed tumor mass

Exclusion criteria

  • 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 BAY85-8050, 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

Treatment and study plan

F-18 (BAY85-8050)

Drug

Cancer patients, injection of BAY 85-8050, PET/CT

Primary outcomes

  1. Visual assessment of lesions

    Time frame: Within up to 2 hours after treatment

Secondary outcomes

  1. Quantitative analysis of BAY 85-8050 uptake into lesions (Standardized Uptake Values, SUVs)

    Time frame: Within up to 2 hours after treatment

  2. Serum chemistry:Glutamate pyruvate transaminase (GPT/ALAT), gamma-glutamyl transferase (gamma-GT), glutamate-oxaloacetate transaminase (GOT), alkaline phosphatase, total bilirubin, creatinine, total protein

    Time frame: At least 2 times within 8 days after treatment

  3. Electrocardiogram (ECG)

    Time frame: at least 2 times within 8 days after treatment

  4. Vital signs: Heart rate, blood pressure

    Time frame: at least 2 times within 8 days after treatment

  5. Adverse events collection

    Time frame: continuously for at least 8 days after treatment

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Open-label, Multicenter Study for an Evaluation of Radiation Dosimetry, Metabolism, Safety and Tolerability of the [F18] Labeled PET (Positron Emission Tomography) Tracer BAY 85-8050 Following a Single Intravenous Administration in Healthy Volunteers, as Well as the Investigation of Safety, Tolerability and Diagnostic Performance of the Tracer in PET/CT (Computer Tomography) in Patients

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Aug 19, 2009
Registry last updated
Oct 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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