Dual PET/CT Imaging in Lung Cancer

NCT ID: NCT01539928

Last Updated: 2013-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

216 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Study Completion Date

2015-03-31

Brief Summary

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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

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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

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Lung Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Dual FDG-PET/CT

Intervention Type OTHER

Conventional FDG-PET/CT preformed after 1 hour and additional PET/CT 3 hours after injection

Interventions

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Dual FDG-PET/CT

Conventional FDG-PET/CT preformed after 1 hour and additional PET/CT 3 hours after injection

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Odense University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mie Holm Vilstrup

Principal investigator, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mie H Vilstrup, MD

Role: PRINCIPAL_INVESTIGATOR

Odense University Hospital

Locations

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Department of Pulmonary Medicine

Odense C, Fünen, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Mie H Vilstrup, MD, Principal investigor

Role: CONTACT

+45 2159 3008

Poul Flemming Høilund-Carlsen, MD, DMSc, Professor

Role: CONTACT

+45 3016 1445

Facility Contacts

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Niels Christian Hansen, MD

Role: primary

Other Identifiers

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NMA 61 DILUCE

Identifier Type: -

Identifier Source: org_study_id

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