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

Phase 4

Terminated

• Conditions: Idiopathic Pulmonary Fibrosis
• Interventions: Procedure: 68Ga-DOTA-NOC PET/CT

• Registration Number: NCT01321996
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief 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.

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2011-03-23
• Study First Submitted QC: 2011-03-23
• Study First Posted: 2011-03-24
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-26
• Last Update Posted: 2015-01-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• Patients with a diagnosis of IPF and NSIP, based on the American Thoracic Society/European Respiratory Society Consensus Conference
• age ≥ 18 years
• males/females
• signed informed consent

Exclusion Criteria

• pregnancy
• breast feeding
• healthy volunteers
• paediatric cases
• patients in emergency situations
• patients legally incompetent
• patients who refuse to sign the informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
68Ga-DOTANOC PET/CT in patients with IPF and NSIP	68Ga-DOTA-NOC PET/CT	one arm study: all patients were studied by 68Ga-DOTANOC PET/CT

Primary Outcome Measures

Name	Time	Method
Describe pattern of 68Ga-DOTA-NOC uptake in comparison with HRCT findings	timeframe between imaging procedures 30 days

Secondary Outcome Measures

Name	Time	Method
68Ga-DOTA-NOC SUVmax correlation with pulmonary function tests	timeframe between PET/CT and pulmonary fucntion tests 30 days

Trial Locations

Locations (1)

Nuclear Medicine, Azienda Ospedaliero Universitaria di Bologna, Policlinico S.Orsola Malpighi; 🇮🇹 Bologna, Italy