Dual PET/CT Imaging in Lung Cancer
DILUCE
1 other identifier
observational
216
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2012
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2012
CompletedFirst Posted
Study publicly available on registry
February 28, 2012
CompletedStudy Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedJune 25, 2013
June 1, 2013
2 years
February 22, 2012
June 24, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Occurence of relapse
1 year follow up after surgery
Study Arms (1)
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
Interventions
Conventional FDG-PET/CT preformed after 1 hour and additional PET/CT 3 hours after injection
Eligibility Criteria
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
You may qualify if:
- 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).
You may not qualify if:
- Former lung cancer
- Contraindications for PET/CT: Pregnancy, recent chemoradiotherapy
- Diabetes mellitus.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Pulmonary Medicine
Odense C, Fünen, 5000, Denmark
Biospecimen
Fresh frozen sample of primary lung cancer tumor
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mie H Vilstrup, MD
Odense University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator, MD
Study Record Dates
First Submitted
February 22, 2012
First Posted
February 28, 2012
Study Start
March 1, 2012
Primary Completion
March 1, 2014
Study Completion
March 1, 2015
Last Updated
June 25, 2013
Record last verified: 2013-06