ClinicalTrials.gov
ClinicalTrials.gov Menu

Dual PET/CT Imaging in Lung Cancer (DILUCE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01539928
Recruitment Status : Unknown
Verified June 2013 by Mie Holm Vilstrup, Odense University Hospital.
Recruitment status was:  Recruiting
First Posted : February 28, 2012
Last Update Posted : June 25, 2013
Sponsor:
Information provided by (Responsible Party):
Mie Holm Vilstrup, Odense University Hospital

Study Description
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

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

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 Design
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Observational
Estimated Enrollment : 216 participants
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)
Study Start Date : March 2012
Estimated Primary Completion Date : March 2014
Estimated Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Groups and Cohorts
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
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


Outcome Measures
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Sensitivity, specificity and accuracy [ Time Frame: 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 :
  1. Occurence of relapse [ Time Frame: 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


Biospecimen Retention:   Samples With DNA
Fresh frozen sample of primary lung cancer tumor

Eligibility Criteria
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted: February 28, 2012    Key Record Dates
Last Update Posted: June 25, 2013
Last Verified: June 2013

Keywords provided by Mie Holm Vilstrup, 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