Clinical trial NCT01321996: 68Ga-DOTA-NOC PET/CT in Patients With Idiopathic Pulmonary Fibrosis
Official title: Employment of 68Ga-DOTA-NOC in Patients With Idiopathic Pulmonary Fibrosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: PET/CT
68Ga-DOTANOC
IPF
NSIP
Idiopathic pulmonary fibrosis
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2011-03-24
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Describe pattern of 68Ga-DOTA-NOC uptake in comparison with HRCT findings
timeFrame: timeframe between imaging procedures 30 days
Secondary outcomes:
measure: 68Ga-DOTA-NOC SUVmax correlation with pulmonary function tests
timeFrame: timeframe between PET/CT and pulmonary fucntion tests 30 days
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Nuclear Medicine, Azienda Ospedaliero Universitaria di Bologna, Policlinico S.Orsola Malpighi
Study officials:
affiliation: Nuclear Medicine, Azienda Ospedaliero Universitaria di Bologna, Policlinico S.Orsola Malpighi, Bologna, Italy
name: Stefano Fanti, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ambrosini V, Zompatori M, De Luca F, Antonia D, Allegri V, Nanni C, Malvi D, Tonveronachi E, Fasano L, Fabbri M, Fanti S. 68Ga-DOTANOC PET/CT allows somatostatin receptor imaging in idiopathic pulmonary fibrosis: preliminary results. J Nucl Med. 2010 Dec;51(12):1950-5. doi: 10.2967/jnumed.110.079962. Epub 2010 Nov 15.