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

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01321996
• Collaborator: (none)
• Enrollment: 29
• Location: 1
• Arm: 1
• Duration (Months): 58
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Idiopathic Pulmonary Fibrosis	Procedure: 68Ga-DOTA-NOC PET/CT	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 29 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Employment of 68Ga-DOTA-NOC in Patients With Idiopathic Pulmonary Fibrosis
• Study Start Date: Feb 1, 2009
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Other: 68Ga-DOTANOC PET/CT in patients with IPF and NSIP one arm study: all patients were studied by 68Ga-DOTANOC PET/CT	Procedure: 68Ga-DOTA-NOC PET/CT; procedure: PET/CT scan with 68Ga-DOTA-NOC

Outcome Measures

Primary Outcome Measures

1. Describe pattern of 68Ga-DOTA-NOC uptake in comparison with HRCT findings [timeframe between imaging procedures 30 days]

Secondary Outcome Measures

1. 68Ga-DOTA-NOC SUVmax correlation with pulmonary function tests [timeframe between PET/CT and pulmonary fucntion tests 30 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nuclear Medicine, Azienda Ospedaliero Universitaria di Bologna, Policlinico S.Orsola Malpighi	Bologna		Italy	40138

Sponsors and Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

• Principal Investigator: Stefano Fanti, Professor, Nuclear Medicine, Azienda Ospedaliero Universitaria di Bologna, Policlinico S.Orsola Malpighi, Bologna, Italy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stefano Fanti, Associate Professor, IRCCS Azienda Ospedaliero-Universitaria di Bologna
• ClinicalTrials.gov Identifier: NCT01321996
• Other Study ID Numbers: CE119/2008/0/Sper
• First Posted: Mar 24, 2011
• Last Update Posted: Jan 27, 2015
• Last Verified: Jan 1, 2015

• Keywords provided by Stefano Fanti, Associate Professor, IRCCS Azienda Ospedaliero-Universitaria di Bologna: PET/CT; 68Ga-DOTANOC; IPF; NSIP; Idiopathic pulmonary fibrosis
• Additional relevant MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis

Study Results

No Results Posted as of Jan 27, 2015