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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
ClinicalTrials.gov Identifier:
NCT01321996
First received: March 23, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted
  Purpose

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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Employment of 68Ga-DOTA-NOC in Patients With Idiopathic Pulmonary Fibrosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi:

Primary Outcome Measures:
  • Describe pattern of 68Ga-DOTA-NOC uptake in comparison with HRCT findings [ Time Frame: timeframe between imaging procedures 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 68Ga-DOTA-NOC SUVmax correlation with pulmonary function tests [ Time Frame: timeframe between PET/CT and pulmonary fucntion tests 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: February 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: 68Ga-DOTA-NOC PET/CT
    procedure: PET/CT scan with 68Ga-DOTA-NOC
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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01321996

Contacts
Contact: Stefano Fanti, Professor +390516363198 stefano.fanti@aosp.bo.it
Contact: Valentina Ambrosini, MD, PhD +390516363187 valentina.ambrosini@aosp.bo.it

Locations
Italy
Nuclear Medicine, Azienda Ospedaliero Universitaria di Bologna, Policlinico S.Orsola Malpighi Recruiting
Bologna, Italy, 40138
Contact: Stefano Fanti, Professor     +390516363198     stefano.fanti@aosp.bo.it    
Principal Investigator: Stefano Fanti, Professor            
Sponsors and Collaborators
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Investigators
Principal Investigator: Stefano Fanti, Professor Nuclear Medicine, Azienda Ospedaliero Universitaria di Bologna, Policlinico S.Orsola Malpighi, Bologna, Italy
  More Information

Publications:

Responsible Party: Professor Stefano Fanti, Azienda Ospedaliero Universitaria di Bologna, Policlinico S.Orsola Malpighi
ClinicalTrials.gov Identifier: NCT01321996     History of Changes
Other Study ID Numbers: CE119/2008/0/Sper
Study First Received: March 23, 2011
Last Updated: March 23, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi:
PET/CT
68Ga-DOTANOC
IPF
NSIP
Idiopathic pulmonary fibrosis

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Pathologic Processes
 Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial

ClinicalTrials.gov processed this record on June 18, 2013