Dual PET/CT Imaging in Lung Cancer (DILUCE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Odense University Hospital
Sponsor:
Information provided by (Responsible Party):
Mie Holm Vilstrup, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01539928
First received: February 22, 2012
Last updated: June 24, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Lung Cancer
Other: Dual FDG-PET/CT

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Dual PET/CT Imaging in Lung Cancer (Danish Title: En og Tre Timers FDG-PET/CT Ved Lungecancer)

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Sensitivity, specificity and accuracy [ Time Frame: After staging or 1 year of follow up ] [ Designated as safety issue: No ]
    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:
  • Occurence of relapse [ Time Frame: 1 year follow up after surgery ] [ Designated as safety issue: No ]
    • To compare SUVmax, RI, tumor/liver ratio, GLUT1 and G-6-Pase with the occurrence of relapse within a year after curative surgery


Biospecimen Retention:   Samples With DNA

Fresh frozen sample of primary lung cancer tumor


Estimated Enrollment: 216
Study Start Date: March 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
lung cancer or high suspicion of lung cancer
After initial work-up (chest x-ray, CT of thorax and upper abdomen, spirometry) found to have surgically resectable lung cancer
Other: Dual FDG-PET/CT
Conventional FDG-PET/CT preformed after 1 hour and additional PET/CT 3 hours after injection

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Pt. referred to The Department of Pulmonary Medicine, Odense University Hospital or The Department of Medicine, Hospital of Southern Denmark, Sønderborg with suspicion of lung cancer

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01539928

Contacts
Contact: Mie H Vilstrup, MD, Principal investigor +45 2159 3008 mie.holm.vilstrup@rsyd.dk
Contact: Poul Flemming Høilund-Carlsen, MD, DMSc, Professor +45 3016 1445 pfhc@rsyd.dk

Locations
Denmark
Department of Pulmonary Medicine Recruiting
Odense C, Fünen, Denmark, 5000
Contact: Niels Christian Hansen, MD       niels.christian.hansen@rsyd.dk   
Sponsors and Collaborators
Odense University Hospital
Investigators
Principal Investigator: Mie H Vilstrup, MD Odense University Hospital
  More Information

No publications provided

Responsible Party: Mie Holm Vilstrup, Principal investigator, MD, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01539928     History of Changes
Other Study ID Numbers: NMA 61 DILUCE
Study First Received: February 22, 2012
Last Updated: June 24, 2013
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

Keywords provided by Odense University Hospital:
Dual time PET/CT
glucose-6-phosphatase

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 22, 2014