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

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

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01321996
Enrollment
29
Registered
2011-03-24
Start date
2009-02-28
Completion date
2013-12-31
Last updated
2015-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

PET/CT, 68Ga-DOTANOC, IPF, NSIP, Idiopathic pulmonary fibrosis

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.

Interventions

PROCEDURE68Ga-DOTA-NOC PET/CT

procedure: PET/CT scan with 68Ga-DOTA-NOC

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Describe pattern of 68Ga-DOTA-NOC uptake in comparison with HRCT findingstimeframe between imaging procedures 30 days

Secondary

MeasureTime frame
68Ga-DOTA-NOC SUVmax correlation with pulmonary function teststimeframe between PET/CT and pulmonary fucntion tests 30 days

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026