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

This study has been terminated.
(enrollment failure (only 29 patients were enrolled during the study period))
Sponsor:
ClinicalTrials.gov Identifier:
NCT01321996
First Posted: March 24, 2011
Last Update Posted: January 27, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Stefano Fanti, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
  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: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Employment of 68Ga-DOTA-NOC in Patients With Idiopathic Pulmonary Fibrosis

Resource links provided by NLM:


Further study details as provided by Stefano Fanti, 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 ]

Secondary Outcome Measures:
  • 68Ga-DOTA-NOC SUVmax correlation with pulmonary function tests [ Time Frame: timeframe between PET/CT and pulmonary fucntion tests 30 days ]

Enrollment: 29
Study Start Date: February 2009
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01321996


Locations
Italy
Nuclear Medicine, Azienda Ospedaliero Universitaria di Bologna, Policlinico S.Orsola Malpighi
Bologna, Italy, 40138
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: Stefano Fanti, Associate Professor, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
ClinicalTrials.gov Identifier: NCT01321996     History of Changes
Other Study ID Numbers: CE119/2008/0/Sper
First Submitted: March 23, 2011
First Posted: March 24, 2011
Last Update Posted: January 27, 2015
Last Verified: January 2015

Keywords provided by Stefano Fanti, 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
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial