NCT01321996

68Ga-DOTA-NOC PET/CT in Patients With Idiopathic Pulmonary Fibrosis

Employment of 68Ga-DOTA-NOC in Patients With Idiopathic Pulmonary Fibrosis

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Idiopathic Pulmonary Fibrosis

Interventions

Type	Name	Description
PROCEDURE	68Ga-DOTA-NOC PET/CT	procedure: PET/CT scan with 68Ga-DOTA-NOC

Timeline

• Start date: 2009-02-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2011-03-24
• Last updated: 2015-01-27

Locations

1 site across 1 country: Italy