Lung CancerDILUCENCT01539928
Dual PET/CT Imaging in Lung Cancer
An observational study of Lung Cancer, run by Odense University Hospital at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Dual FDG-PET/CT
- Type of treatment
- Injection or infusion
- How many people
- 216 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2012to Mar 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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).
Who cannot join
- Former lung cancer
- Contraindications for PET/CT: Pregnancy, recent chemoradiotherapy
- Diabetes mellitus.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of Pulmonary Medicine
Odense C, Fünen, 5000
Niels Christian Hansen, MD, niels.christian.hansen@rsyd.dk
About this study
Official title: Dual PET/CT Imaging in Lung Cancer (Danish Title: En og Tre Timers FDG-PET/CT Ved Lungecancer)
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.
Read the 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
- Conditions
- Lung Cancer
- Being tested
- Dual FDG-PET/CT
- Keywords
- Dual time PET/CT, glucose-6-phosphatase
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual FDG-PET/CTOther
Conventional FDG-PET/CT preformed after 1 hour and additional PET/CT 3 hours after injection
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Dual FDG-PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: After staging or 1 year of follow up
Secondary outcomes (1)
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
Measured: 1 year follow up after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionMar 2014 (estimated)
- Study completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mie Holm Vilstrup, Odense University Hospital
- Investigators
- Mie H Vilstrup, MD, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01539928
- Sponsor's protocol ID
- NMA 61 DILUCE
- Acronym
- DILUCE
- Status last verified
- Jun 2013
- First submitted
- 22 Feb 2012
- Last updated
- 25 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual PET/CT Imaging in Lung Cancer (Danish Title: En og Tre Timers FDG-PET/CT Ved Lungecancer)
- ClinicalTrials.gov ID
- NCT01539928
- Acronym / sponsor ID
- DILUCE / NMA 61 DILUCE
- Conditions
- Lung Cancer
- Keywords
- Dual time PET/CT, glucose-6-phosphatase
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 28 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lung cancer or high suspicion of lung cancer | – | Other: Dual FDG-PET/CTAfter initial work-up (chest x-ray, CT of thorax and upper abdomen, spirometry) found to have surgically resectable lung cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (3 listed)
- Former lung cancer
- Contraindications for PET/CT: Pregnancy, recent chemoradiotherapy
- Diabetes mellitus.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dual FDG-PET/CTConventional FDG-PET/CT preformed after 1 hour and additional PET/CT 3 hours after injection | Other | lung cancer or high suspicion of lung cancer |
Primary outcome
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
1 secondary outcome
Occurence of relapse
Time frame: 1 year follow up after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2013.
Related trials for Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mie H Vilstrup, MD principal investigator
Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mie H Vilstrup, MD, Principal investigor (+45 2159 3008, mie.holm.vilstrup@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity, specificity and accuracy (time frame: After staging or 1 year of follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2013.