Dual PET/CT Imaging in Lung Cancer

• Conditions: Lung Cancer
• Interventions: Other: Dual FDG-PET/CT

• Registration Number: NCT01539928
• Lead Sponsor: Odense University Hospital

Brief Summary

The purpose of this study is to compare conventional PET/CT scan performed 1 hour after injection of the radioactive tracer FDG (PET/CT\[1\]) with PET/CT performed after 3 hours (PET/CT\[3\]) in a group of patients with biopsy verified lung cancer or high suspicion of lung cancer after initial work-up (chest x-ray and CT of thorax/upper abdomen), who are potentially operable.

Detailed Description

The investigators also want to:

* To find the sensitivity, specificity and accuracy in PET/CT 1h and 3 h in the staging of lung cancer (N-/M-stage). Our gold standard is pathology, when not possible - follow-up (se Gold Standard 6.1.1)

* To compare SUVmax with the expression of GLUT1 and G-6-Pase in tumors

* To compare the expression of GLUT1 with the activity of G6Pase

* To compare SUVmax, RI, tumor/liver ratio, GLUT1 and G-6-Pase with the occurrence of relapse within a year after curative surgery

Study Timeline

• Study First Submitted: 2012-02-22
• Study First Submitted QC: 2012-02-27
• Study First Posted: 2012-02-28
• Study Start: 2012-03
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-24
• Last Update Posted: 2013-06-25
• Primary Completion: 2014-03
• Study Completion: 2015-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 216

Inclusion Criteria

• Cytologic/histologic-verified lung cancer or high suspicion of lung cancer after initial work up
• Candidate to curative intended surgery after initial work up (usually chest x-ray, CT of chest/upper abdomen and if needed spirometry).

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Exclusion Criteria

• Former lung cancer
• Contraindications for PET/CT: Pregnancy, recent chemoradiotherapy
• Diabetes mellitus.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
lung cancer or high suspicion of lung cancer	Dual FDG-PET/CT	After initial work-up (chest x-ray, CT of thorax and upper abdomen, spirometry) found to have surgically resectable lung cancer

Primary Outcome Measures

Name	Time	Method
Sensitivity, specificity and accuracy	After staging or 1 year of follow up	To find the sensitivity, specificity and accuracy in PET/CT 1h and 3 h in the staging of lung cancer (N-/M-stage). Our gold standard is pathology, when not possible - follow-up

Secondary Outcome Measures

Name	Time	Method
Occurence of relapse	1 year follow up after surgery	• To compare SUVmax, RI, tumor/liver ratio, GLUT1 and G-6-Pase with the occurrence of relapse within a year after curative surgery

Trial Locations

Locations (1)

Department of Pulmonary Medicine; 🇩🇰 Odense C, Fünen, Denmark