ltra-long Field-Of-View Positron Emission Tomography for characterization of indeterminate lung nodules: a pilot study exploring opportunities for clinical research

Conditions: indeterminate lung nodule
spot on the lung
10038666
10029107

Registration Number: NL-OMON51268

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

18 years or older
able to give informed consent
signed informed consent
confirmed indeterminate lung nodule(s) of 6-15 mm in size on CT chest imaging
routine [18]F-FDG PET/CT
scheduled for biopsy or surgical removal of the lung nodule(s)

Exclusion Criteria

claustrophobic
pregnant or breastfeeding women
interval of at least 2 weeks between PET scan and last date of systemic
anti-cancer therapy
radiation therapy of the target lung nodule(s)
uncontrolled diabetes mellitus
any medical condition potentially hampering conduction of the trial

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study endpoint is a technical performance assessment of lung nodule<br /><br>characterization using the Vision Quadra PET/CT. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To develop an optimized long FOV PET/CT imaging procedure (with regard to<br /><br>optimal scan duration and reconstruction parameters) for detection and<br /><br>characterization of indeterminate lung nodules, and to obtain preliminary data<br /><br>on sensitivity, specificity, and accuracy of PET imaging using the Vision<br /><br>Quadra PET/CT for small, indeterminate lung nodules. </p><br>