Study Stopped
enrollment failure (only 29 patients were enrolled during the study period)
68Ga-DOTA-NOC PET/CT in Patients With Idiopathic Pulmonary Fibrosis
Employment of 68Ga-DOTA-NOC in Patients With Idiopathic Pulmonary Fibrosis
1 other identifier
interventional
29
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Feb 2009
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 23, 2011
CompletedFirst Posted
Study publicly available on registry
March 24, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedJanuary 27, 2015
January 1, 2015
4.8 years
March 23, 2011
January 26, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Describe pattern of 68Ga-DOTA-NOC uptake in comparison with HRCT findings
timeframe between imaging procedures 30 days
Secondary Outcomes (1)
68Ga-DOTA-NOC SUVmax correlation with pulmonary function tests
timeframe between PET/CT and pulmonary fucntion tests 30 days
Study Arms (1)
68Ga-DOTANOC PET/CT in patients with IPF and NSIP
OTHERone arm study: all patients were studied by 68Ga-DOTANOC PET/CT
Interventions
procedure: PET/CT scan with 68Ga-DOTA-NOC
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- pregnancy
- breast feeding
- healthy volunteers
- paediatric cases
- patients in emergency situations
- patients legally incompetent
- patients who refuse to sign the informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nuclear Medicine, Azienda Ospedaliero Universitaria di Bologna, Policlinico S.Orsola Malpighi
Bologna, 40138, Italy
Related Publications (1)
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.
PMID: 21078794RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stefano Fanti, Professor
Nuclear Medicine, Azienda Ospedaliero Universitaria di Bologna, Policlinico S.Orsola Malpighi, Bologna, Italy
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
March 23, 2011
First Posted
March 24, 2011
Study Start
February 1, 2009
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
January 27, 2015
Record last verified: 2015-01