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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Idiopathic Pulmonary Fibrosis

Intervention / Treatment
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* Procedure: 68Ga-DOTA-NOC PET/CT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 68Ga-DOTANOC PET/CT in patients with IPF and NSIP<br>one arm study: all patients were studied by 68Ga-DOTANOC PET/CT | Procedure: 68Ga-DOTA-NOC PET/CT<br>* procedure: PET/CT scan with 68Ga-DOTA-NOC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe pattern of 68Ga-DOTA-NOC uptake in comparison with HRCT findings |  | timeframe between imaging procedures 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 68Ga-DOTA-NOC SUVmax correlation with pulmonary function tests |  | timeframe between PET/CT and pulmonary fucntion tests 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PET/CT, 68Ga-DOTANOC, IPF, NSIP, Idiopathic pulmonary fibrosis