68Ga-DOTA-NOC PET/CT in Patients With Idiopathic Pulmonary Fibrosis
Recruitment status was Recruiting
The investigators aim to evaluate the role of 68Ga-DOTA-NOC PET/CT in patients with idiopathic pulmonary fibrosis, in particular in patients with a diagnosis of IPF/UIP (idiopathic pulmonary fibrosis, diagnosed based in the American Thoracic Society and European Respiratory Society criteria) and in forms of NSIP (non-specific interstitial pneumonia). PET/CT imaging data will be compared with HRCT (high-resolution computed tomography) findings to assess disease extension, early disease detection and to non-invasively detect somatostatin receptors expression at lung level in these patients, with potential therapeutic implications.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Employment of 68Ga-DOTA-NOC in Patients With Idiopathic Pulmonary Fibrosis|
- Describe pattern of 68Ga-DOTA-NOC uptake in comparison with HRCT findings [ Time Frame: timeframe between imaging procedures 30 days ] [ Designated as safety issue: No ]
- 68Ga-DOTA-NOC SUVmax correlation with pulmonary function tests [ Time Frame: timeframe between PET/CT and pulmonary fucntion tests 30 days ] [ Designated as safety issue: No ]
|Study Start Date:||February 2009|
|Estimated Study Completion Date:||December 2011|
|Estimated Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
Procedure: 68Ga-DOTA-NOC PET/CT
Idiopathic pulmonary fibrosis prognosis remains severe, in particular for IPF, the most common entity. Moreover, current treatment options are largely ineffective and do not change the natural course of the disease. Pre-clinical evidence supports somatostatin receptors expression in the lung of patients with IPF. Recently new PET tracers (Somatostatin analogues labelled with 68Gallium), specifically binding to somatostatin receptors, have been developed and are used in neuroendocrine tumours clinical trials.
Aim of the present study is to evaluate the role of 68Ga-DOTA-NOC PET/CT in patients with idiopathic pulmonary fibrosis, in particular in patients with IPF/UIP and in cases with NSIP, that are characterized by a more indolent progression. PET/CT data will be compared with HRCT findings for the early detection of fibrotic areas and to non-invasively assess somatostatin receptors expression at lung level in these patients, with potential therapeutic implications. Moreover, the SUVmax (maximum standardized uptake value) will be analyzed in comparison with disease site and extension on HRCT.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01321996
|Contact: Stefano Fanti, Professoremail@example.com|
|Contact: Valentina Ambrosini, MD, PhDfirstname.lastname@example.org|
|Nuclear Medicine, Azienda Ospedaliero Universitaria di Bologna, Policlinico S.Orsola Malpighi||Recruiting|
|Bologna, Italy, 40138|
|Contact: Stefano Fanti, Professor +390516363198 email@example.com|
|Principal Investigator: Stefano Fanti, Professor|
|Principal Investigator:||Stefano Fanti, Professor||Nuclear Medicine, Azienda Ospedaliero Universitaria di Bologna, Policlinico S.Orsola Malpighi, Bologna, Italy|