68Ga-DOTA-NOC PET/CT in Patients With Idiopathic Pulmonary Fibrosis
Primary Purpose
Idiopathic Pulmonary Fibrosis
Status
Terminated
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
68Ga-DOTA-NOC PET/CT
Sponsored by
About this trial
This is an interventional diagnostic trial for Idiopathic Pulmonary Fibrosis focused on measuring PET/CT, 68Ga-DOTANOC, IPF, NSIP, Idiopathic pulmonary fibrosis
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
Sites / Locations
- Nuclear Medicine, Azienda Ospedaliero Universitaria di Bologna, Policlinico S.Orsola Malpighi
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
68Ga-DOTANOC PET/CT in patients with IPF and NSIP
Arm Description
one arm study: all patients were studied by 68Ga-DOTANOC PET/CT
Outcomes
Primary Outcome Measures
Describe pattern of 68Ga-DOTA-NOC uptake in comparison with HRCT findings
Secondary Outcome Measures
68Ga-DOTA-NOC SUVmax correlation with pulmonary function tests
Full Information
NCT ID
NCT01321996
First Posted
March 23, 2011
Last Updated
January 26, 2015
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1. Study Identification
Unique Protocol Identification Number
NCT01321996
Brief Title
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
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Terminated
Why Stopped
enrollment failure (only 29 patients were enrolled during the study period)
Study Start Date
February 2009 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis
Keywords
PET/CT, 68Ga-DOTANOC, IPF, NSIP, Idiopathic pulmonary fibrosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
68Ga-DOTANOC PET/CT in patients with IPF and NSIP
Arm Type
Other
Arm Description
one arm study: all patients were studied by 68Ga-DOTANOC PET/CT
Intervention Type
Procedure
Intervention Name(s)
68Ga-DOTA-NOC PET/CT
Intervention Description
procedure: PET/CT scan with 68Ga-DOTA-NOC
Primary Outcome Measure Information:
Title
Describe pattern of 68Ga-DOTA-NOC uptake in comparison with HRCT findings
Time Frame
timeframe between imaging procedures 30 days
Secondary Outcome Measure Information:
Title
68Ga-DOTA-NOC SUVmax correlation with pulmonary function tests
Time Frame
timeframe between PET/CT and pulmonary fucntion tests 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefano Fanti, Professor
Organizational Affiliation
Nuclear Medicine, Azienda Ospedaliero Universitaria di Bologna, Policlinico S.Orsola Malpighi, Bologna, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nuclear Medicine, Azienda Ospedaliero Universitaria di Bologna, Policlinico S.Orsola Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
21078794
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.
Results Reference
result
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68Ga-DOTA-NOC PET/CT in Patients With Idiopathic Pulmonary Fibrosis
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