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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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19 March 2012 |
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Main ID: |
EUCTR2010-020223-44-AT |
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Date of registration:
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29/06/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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(18)F-FDG PET/CT in patients with idiopathic interstitial pneumonias: correlation of tracer uptake and histological findings, and texture-based recognition of usual interstitial pneumonia
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Scientific title:
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(18)F-FDG PET/CT in patients with idiopathic interstitial pneumonias: correlation of tracer uptake and histological findings, and texture-based recognition of usual interstitial pneumonia |
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Date of first enrolment:
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03/08/2010 |
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Target sample size:
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Recruitment status: |
Authorised-recruitment may be ongoing or finished |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-020223-44 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised: no
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
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Phase:
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Countries of recruitment
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Austria
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
• symptoms of dyspnea and dry cough
• clinical suspicion of an IIP
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
• previous drug therapy of the IIP
• pregnancy
• inability to understand the study goals or outline, or to consent to participate
• age below the specified minimum of 18 years.
• at a second time point: absence of tissue alterations, compatible with IIPs, on PET/CT images
• at a third time point: patients for whom the suspicion of IIP is not confirmed by biopsy / histological workup
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Interstitial lung disease of unknown etiology
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Intervention(s)
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Trade Name: (18)F-FDG
Product Name: (18)F-FDG
Pharmaceutical Form: Solution for injection
INN or Proposed INN: FLUORINE (18F) FLUDEOXYGLUCOSE
CAS Number: 105851-17-0
Concentration unit: MBq megabecquerel(s)
Concentration type: equal
Concentration number: 300 MBq-
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Primary Outcome(s)
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Secondary Objective: To determine whether computer-assisted texture-based pattern recognition of PET/CT images can distinguish between usual interstitial pneumonia (UIP) and other IIP subtypes.
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Main Objective: To demonstrate the ability of (18)F-FDG PET/CT to detect active disease in patients with idiopathic interstitial pneumonias (IIP).
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Primary end point(s): • Areas with active, histologically verified IIP show a increased tracer uptake in (18)F-FDG PET/CT
• Texture-based pattern recognition is able to distinguish between UIP and other IIPs
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Secondary ID(s)
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FinalVersion
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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