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

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status and phase: Terminated; Phase 4

Conditions: Idiopathic Pulmonary Fibrosis

Treatments: Procedure: 68Ga-DOTA-NOC PET/CT

Study type: Interventional

Funder types: Other

Identifiers

NCT01321996

CE119/2008/0/Sper

Details and patient eligibility

About

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.

Full 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.

Enrollment: 29 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

68Ga-DOTANOC PET/CT in patients with IPF and NSIP

Other group

Description:

one arm study: all patients were studied by 68Ga-DOTANOC PET/CT

Treatment:

Procedure: 68Ga-DOTA-NOC PET/CT