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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: |
EUCTR2008-007168-40-IT |
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Date of registration:
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09/03/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Use of 68Ga-DOTA-NOC for the evaluation of patients with Idiopathic pulmonary fibrosis
STUDY CODE: 68Ga-DOTA-NOC/ILD 01/2008 - 68Ga-DOTA-NOC/ILD01/2008
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Scientific title:
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Use of 68Ga-DOTA-NOC for the evaluation of patients with Idiopathic pulmonary fibrosis
STUDY CODE: 68Ga-DOTA-NOC/ILD 01/2008 - 68Ga-DOTA-NOC/ILD01/2008 |
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Date of first enrolment:
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20/01/2009 |
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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:2008-007168-40 |
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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:
Placebo:
Other:
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Phase:
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Countries of recruitment
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Italy
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Diagnosis of Idiopathic Pulmonary Fibrosis (IPF, NSIP)
2. Age > 18
3. Informed consent signed
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:
1. Pregnancy
2. Breast feeding
3. Healthy volunteers
4. Age <18
5. Patients in emergency state
6. Individuals with reduced approval competence expressing any reluctance to participate to the study as well as those not understanding the purpose of the study
7. Informed consent not signed
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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patients with Idiopathic pulmonary fibrosis
MedDRA version: 9.1
Level: LLT
Classification code 10021240
Term: Idiopathic pulmonary fibrosis
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Intervention(s)
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Product Name: Gallium68-Dota-Noc
Pharmaceutical Form: Solution for injection
Concentration unit: MBq megabecquerel(s)
Concentration type: equal
Concentration number: 185-
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Primary Outcome(s)
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Primary end point(s): To evaluate the sensitivity of 68Ga-DOTA-NOC PET/CT for the assessment of idiopatic pulmonary fibrosis. Comparison of the extension of fibrosis detected by vs HRCT and prognostic value of SUV compared to HRCT parameter and Pulmonary Function Tests
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Main Objective: To evaluate the sensitivity of 68Ga-DOTA-NOC PET/CT for the assessment of Idiopathic Pulmonary Fibrosis patients, in particular IPF and NSIP cases, comparing PET/CT results with data obtained with routinely performed HRCT and pulmonary function tests.
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Secondary Objective: Secondary aim is to identify novel therapeutic strategies for these patients. In particular the possibility to visualize somatostain receptor expression in vivo by 68Ga-DOTA-NOC PET/CT allows the selection of patient potentially candidated to receptor targeted therapy.
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Secondary ID(s)
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68Ga-DOTA-NOC/ILD01/2008
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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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URL:
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