Idiopathic Pulmonary FibrosisPhase 4NCT01321996
68Ga-DOTA-NOC PET/CT in Patients With Idiopathic Pulmonary Fibrosis
A Phase 4 study testing 68Ga-DOTA-NOC PET/CT in people with Idiopathic Pulmonary Fibrosis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- 68Ga-DOTA-NOC PET/CT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2009to Dec 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- pregnancy
- breast feeding
- healthy volunteers
- paediatric cases
- patients in emergency situations
- patients legally incompetent
- patients who refuse to sign the informed consent
Trial locations and contacts
1 site in 1 country.
Italy1 site
Nuclear Medicine, Azienda Ospedaliero Universitaria di Bologna, Policlinico S.Orsola Malpighi
Bologna, 40138
About this study
Official title: 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.
Read the 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.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- 68Ga-DOTA-NOC PET/CT
- Keywords
- PET/CT, 68Ga-DOTANOC, IPF, NSIP, Idiopathic pulmonary fibrosis
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-DOTA-NOC PET/CTProcedure or surgery
procedure: PET/CT scan with 68Ga-DOTA-NOC
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-DOTANOC PET/CT in patients with IPF and NSIP | Other | one arm study: all patients were studied by 68Ga-DOTANOC PET/CT Receives: Procedure: 68Ga-DOTA-NOC PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe pattern of 68Ga-DOTA-NOC uptake in comparison with HRCT findings
Measured: timeframe between imaging procedures 30 days
Secondary outcomes (1)
68Ga-DOTA-NOC SUVmax correlation with pulmonary function tests
Measured: timeframe between PET/CT and pulmonary fucntion tests 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2011 (estimated)
- Study startFeb 2009
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: enrollment failure (only 29 patients were enrolled during the study period)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Fanti, IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Investigators
- Stefano Fanti, Professor, Principal investigator, Nuclear Medicine, Azienda Ospedaliero Universitaria di Bologna, Policlinico S.Orsola Malpighi, Bologna, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01321996
- Sponsor's protocol ID
- CE119/2008/0/Sper
- Status last verified
- Jan 2015
- First submitted
- 23 Mar 2011
- Last updated
- 27 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21078794
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Employment of 68Ga-DOTA-NOC in Patients With Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT01321996
- Acronym / sponsor ID
- CE119/2008/0/Sper
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- PET/CT, 68Ga-DOTANOC, IPF, NSIP, Idiopathic pulmonary fibrosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: enrollment failure (only 29 patients were enrolled during the study period)
- Enrolment
- 29 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 24 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-DOTANOC PET/CT in patients with IPF and NSIP | Other | Procedure: 68Ga-DOTA-NOC PET/CTone arm study: all patients were studied by 68Ga-DOTANOC PET/CT |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- pregnancy
- breast feeding
- healthy volunteers
- paediatric cases
- patients in emergency situations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-DOTA-NOC PET/CTprocedure: PET/CT scan with 68Ga-DOTA-NOC | Procedure or surgery | 68Ga-DOTANOC PET/CT in patients with IPF and NSIP |
Primary outcome
Describe pattern of 68Ga-DOTA-NOC uptake in comparison with HRCT findings
Time frame: timeframe between imaging procedures 30 days
1 secondary outcome
68Ga-DOTA-NOC SUVmax correlation with pulmonary function tests
Time frame: timeframe between PET/CT and pulmonary fucntion tests 30 days
Results and safety
The study was stopped early (reason given: enrollment failure (only 29 patients were enrolled during the study period)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2015.
- Results publication: PubMed 21078794Ambrosini 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefano Fanti, Professor principal investigator
Nuclear Medicine, Azienda Ospedaliero Universitaria di Bologna, Policlinico S.Orsola Malpighi, Bologna, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 68Ga-DOTA-NOC PET/CT in people with Idiopathic Pulmonary Fibrosis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: enrollment failure (only 29 patients were enrolled during the study period)). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe pattern of 68Ga-DOTA-NOC uptake in comparison with HRCT findings (time frame: timeframe between imaging procedures 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01321996, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2015.