Dual PET/CT Imaging in Lung Cancer

Lung Cancer Clinical Trial

— DILUCE  

Official title:

Dual PET/CT Imaging in Lung Cancer (Danish Title: En og Tre Timers FDG-PET/CT Ved Lungecancer)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01539928
• Other study ID #: NMA 61 DILUCE
• Status: Recruiting
• Phase: N/A
• First received: February 22, 2012
• Last updated: June 24, 2013
• Start date: March 2012
• Est. completion date: March 2015

Study information

• Verified date: June 2013
• Source: Odense University Hospital
• Contact: Mie H Vilstrup, MD, Principal investigor
• Phone: +45 2159 3008
• Email: mie.holm.vilstrup[@]rsyd.dk
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 216
• Est. completion date: March 2015
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Exclusion Criteria:

• Former lung cancer

• Contraindications for PET/CT: Pregnancy, recent chemoradiotherapy

• Diabetes mellitus.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Other:
• Dual FDG-PET/CT
Conventional FDG-PET/CT preformed after 1 hour and additional PET/CT 3 hours after injection

Locations

Country	Name	City	State
Denmark	Department of Pulmonary Medicine	Odense C	Fünen

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity, specificity and accuracy	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	After staging or 1 year of follow up	No
Secondary	Occurence of relapse	• To compare SUVmax, RI, tumor/liver ratio, GLUT1 and G-6-Pase with the occurrence of relapse within a year after curative surgery	1 year follow up after surgery	No