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:
Odense University Hospital
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
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 |
ClinicalTrials.gov processed this record on March 03, 2015