Positron Emission Tomography (PET)/Computed Tomography (CT) and Roentgen in Lung Cancer: Evaluation of Patients in General Practice (PROLOG)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Odense University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT00675168
First received: May 6, 2008
Last updated: February 18, 2009
Last verified: February 2009
  Purpose

The prognosis of lung cancer depends much on the stage of the disease at the time of diagnosis. Only 16 % of lung cancer can be offered curative intended surgery. Chest x-ray is the gate-keeper in lung cancer diagnosis, but it has a miss rate of 20-60 %. A false negative chest x-ray often causes prolonged delay in diagnosis - often months.

Recently a "48 hour diagnosis guaranty" has been implemented, which helps accelerate the system delay (delay from referral to diagnosis). But chest x-ray is still the gate-keeper; if the chest x-ray is negative further examination ceases.

PET/CT has a higher sensitivity (96 %), than chest x-ray. In the latter years only little improvement in the survival rate of lung cancer has been made. Screening studies is currently been performed, but it's time for innovative thinking. PET/CT has established its place in the staging of lung cancer. But studies like this may help to place PET/CT in the chain of examination making it more cost-beneficial.

The overall aim of this study is to improve patient course with earlier diagnosis of lung cancer.


Condition Intervention Phase
Lung Cancer
Radiation: PET/CT (low-dose)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: PET/CT and Roentgen in Lung Cancer. Evaluation of Patients in General Practice

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Sensitivity and specificity of chest x-ray and PET/CT in Lung Cancer [ Time Frame: min. two years of follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Positive/negative predictive values of chest x-ray and PET/CT Operability - surrogate for survival Numbers of false positive PET/CT Numbers of false negative PET/CT Numbers of invasive procedures Cost-effectiveness [ Time Frame: min. two years of follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 1700
Study Start Date: May 2008
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: PET/CT (low-dose)
    400 mBq 18F-flour-deoxyglucose given iv. 60 min. before PET/CT-scan
    Other Name: FDG
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   60 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pt. referred from general practice to a chest x-ray
  • age 60-80 years
  • current or former smoker

Exclusion Criteria:

  • previously diagnosed with lung cancer
  • contraindications to PET/CT
  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: NCT00675168

Contacts
Contact: Mie Jung Nielsen, MD 0045-6541-2981 mie.nielsen@ouh.regionsyddanmark.dk
Contact: Poul Flemming Højlund Carlsen, MD, Professor, DMSc 0045-6541-2981

Locations
Denmark
Department of Nuclear Medicine Not yet recruiting
Odense, Funen, Denmark, 5000
Contact: Poul Flemming Højlund Carlsen, MD, Professor, DMSc    45-6541-2981      
Contact: Allan Johansen, MD, Head of Department    45-6541-2981      
Principal Investigator: Mie Jung Nielsen, MD         
Recruiting
Odense, Fünen, Denmark
Contact: Nielsen       mie.jni@gmail.com   
Recruiting
Odense, Fünen, Denmark
Contact: Nielsen, MD       mie.jni@gmail.com   
Sponsors and Collaborators
Odense University Hospital
  More Information

No publications provided

Responsible Party: Mie Jung Nielsen, MD, Odense University Hospital, Department of Nuclear Medicine
ClinicalTrials.gov Identifier: NCT00675168     History of Changes
Other Study ID Numbers: PROLOG
Study First Received: May 6, 2008
Last Updated: February 18, 2009
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Odense University Hospital:
Lung Cancer
PET/CT
Diagnosis

Additional relevant MeSH terms:
Lung Neoplasms
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 20, 2014