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

January 26, 2015 updated by: Stefano Fanti, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Employment of 68Ga-DOTA-NOC in Patients With Idiopathic Pulmonary Fibrosis

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40138
        • Nuclear Medicine, Azienda Ospedaliero Universitaria di Bologna, Policlinico S.Orsola Malpighi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Describe pattern of 68Ga-DOTA-NOC uptake in comparison with HRCT findings
Time Frame: timeframe between imaging procedures 30 days
timeframe between imaging procedures 30 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

March 23, 2011

First Submitted That Met QC Criteria

March 23, 2011

First Posted (Estimate)

March 24, 2011

Study Record Updates

Last Update Posted (Estimate)

January 27, 2015

Last Update Submitted That Met QC Criteria

January 26, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE119/2008/0/Sper

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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