Pleural DiseasesNCT03172585
Transthoracic Sonography Versus High Resolution Computed Tomography in Alveolar Intersitial Syndrome
A study testing High resolution computed tomography and trans thoracic ultrasonography in people with Pleural Diseases, run by Assiut University.
Trial summary
High resolution computed tomography of the chest is the gold standard imaging modality for most pulmonary diseases. However, the associated high expenses, radiation exposure , and its limited possibility for bedside use are a limitation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Diseases
- What is being tested?
- High resolution computed tomography and trans thoracic ultrasonography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Jun 2017to Aug 2018
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients presenting with dyspnea due to interstitial fibrosis syndrome.
- pulmonary edema due to any cause.
Who cannot join
- Traumatic lesions
- Pneumothorax
- Subcutaneous emphysema
- Massive pleural effusion with atelectasis, and
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Can High Frequency Transthoracic Sonography Play a Competition Role With High Resolution Computed Tomography in Assessment of Alveolar Intersitial Syndrome
High resolution computed tomography of the chest is the gold standard imaging modality for most pulmonary diseases. However, the associated high expenses, radiation exposure , and its limited possibility for bedside use are a limitation.
Read the detailed description
High resolution computed tomography of the chest is the gold standard imaging modality for most pulmonary diseases. However, the associated high expenses, radiation exposure , and its limited possibility for bedside use are a limitation. Transthoracic ultrasonograghy is used progressively for evaluation of pulmonary diseases. Its non invasive nature , relatively low price ,portability for bedside use, and high reproducibility of results allows for incorporation of imaging findings with clinical data. Although Transthoracic ultrasonograghy is not an alternative to High resolution computed tomography,it can potentially provide useful supplemental information in certain specific situations ,such as for rapid bedside diagnostic assessment of dyspneic patients. B-line is a common and significant abnormal sign used for diagnostic appraisal by Transthoracic ultrasonograghy, but it cannot define the exact underlying pathologic feature on a lung ultrasound. When the lung parenchymal pathology reaches the lung surface ,certain characteristic changes of the pleural line can be detected by means of the good imaging made possible by high-resolution Transthoracic ultrasonograghy ,but the application and strength of pleural line abnormalities in the differential diagnosis of lung diseases has not been adequately explored . Existing literature on the illustration of the pleural line is scarce ,and the shape of pleural line has not been adequately investigated and described ,especially in comparison with Computed tomography findings. Most studies that have investigated pleural lines are confined to the sub population with interstitial lung diseases.
- Conditions
- Pleural Diseases
- Being tested
- High resolution computed tomography, trans thoracic ultrasonography
- Medical subject headings
- Pleural Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High resolution computed tomographyOther
High resolution computed tomography of the chest is the gold standard imaging modality for most pulmonary diseases
trans thoracic ultrasonographyOther
Trans thoracic ultrasonograghy is used progressively for evaluation of pulmonary diseases . Its non invasive nature , relatively low price ,portability for bedside use, and high reproducible of results allows for incorporation of imaging findings with clinical data
| Study group | Role | What they receive |
|---|---|---|
| High Resolution computed tomography | Other | Patients will be included in the study when High resolution chest computed tomography without contrast enhancement is ordered by the primary physician. Before the High resolution chest computed tomography scan, a Trans thoracic ultrasonography will be performed. Receives: Other: High resolution computed tomography; Other: trans thoracic ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of patients diagnosed with pleural diseases by high resolution computed tomography
computed tomography on the chest
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2017
- Study startJun 2017 (estimated)
- Primary completionJun 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pleural DiseasesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mariam hany adeeb, Assiut University
- Investigators
- Manal Mohamed, MD, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03172585
- Sponsor's protocol ID
- AIS
- Status last verified
- May 2017
- First submitted
- 26 May 2017
- Last updated
- 1 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sartori S, Tombesi P. Emerging roles for transthoracic ultrasonography in pleuropulmonary pathology. World J Radiol. 2010 Feb 28;2(2):83-90. doi: 10.4329/wjr.v2.i2.83.
PubMed 21160921Frenz MB, Mee AS. Diagnostic radiation exposure and cancer risk. Gut. 2005 Jun;54(6):889-90. doi: 10.1136/gut.2005.066605. No abstract available.
PubMed 15888804Volpicelli G, Mussa A, Garofalo G, Cardinale L, Casoli G, Perotto F, Fava C, Frascisco M. Bedside lung ultrasound in the assessment of alveolar-interstitial syndrome. Am J Emerg Med. 2006 Oct;24(6):689-96. doi: 10.1016/j.ajem.2006.02.013.
PubMed 16984837Smargiassi A, Inchingolo R, Soldati G, Copetti R, Marchetti G, Zanforlin A, Giannuzzi R, Testa A, Nardini S, Valente S. The role of chest ultrasonography in the management of respiratory diseases: document II. Multidiscip Respir Med. 2013 Aug 9;8(1):55. doi: 10.1186/2049-6958-8-55.
PubMed 23937897Leech M, Bissett B, Kot M, Ntoumenopoulos G. Lung ultrasound for critical care physiotherapists: a narrative review. Physiother Res Int. 2015 Jun;20(2):69-76. doi: 10.1002/pri.1607. Epub 2014 Dec 29.
PubMed 25545613Lichtenstein D, Meziere G, Biderman P, Gepner A, Barre O. The comet-tail artifact. An ultrasound sign of alveolar-interstitial syndrome. Am J Respir Crit Care Med. 1997 Nov;156(5):1640-6. doi: 10.1164/ajrccm.156.5.96-07096.
PubMed 9372688
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can High Frequency Transthoracic Sonography Play a Competition Role With High Resolution Computed Tomography in Assessment of Alveolar Intersitial Syndrome
- ClinicalTrials.gov ID
- NCT03172585
- Acronym / sponsor ID
- AIS
- Conditions
- Pleural Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2017 (estimated)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 1 Jun 2017 (actual)
- 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.
High resolution computed tomography of the chest is the gold standard imaging modality for most pulmonary diseases. However, the associated high expenses, radiation exposure , and its limited possibility for bedside use are a limitation.
Detailed description
High resolution computed tomography of the chest is the gold standard imaging modality for most pulmonary diseases. However, the associated high expenses, radiation exposure , and its limited possibility for bedside use are a limitation. Transthoracic ultrasonograghy is used progressively for evaluation of pulmonary diseases. Its non invasive nature , relatively low price ,portability for bedside use, and high reproducibility of results allows for incorporation of imaging findings with clinical data. Although Transthoracic ultrasonograghy is not an alternative to High resolution computed tomography,it can potentially provide useful supplemental information in certain specific situations ,such as for rapid bedside diagnostic assessment of dyspneic patients. B-line is a common and significant abnormal sign used for diagnostic appraisal by Transthoracic ultrasonograghy, but it cannot define the exact underlying pathologic feature on a lung ultrasound. When the lung parenchymal pathology reaches the lung surface ,certain characteristic changes of the pleural line can be detected by means of the good imaging made possible by high-resolution Transthoracic ultrasonograghy ,but the application and strength of pleural line abnormalities in the differential diagnosis of lung diseases has not been adequately explored . Existing literature on the illustration of the pleural line is scarce ,and the shape of pleural line has not been adequately investigated and described ,especially in comparison with Computed tomography findings. Most studies that have investigated pleural lines are confined to the sub population with interstitial lung diseases.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High Resolution computed tomography | Other | Other: High resolution computed tomography, Other: trans thoracic ultrasonographyPatients will be included in the study when High resolution chest computed tomography without contrast enhancement is ordered by the primary physician. Before the High resolution chest computed tomography scan, a Trans thoracic ultrasonography will be performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients presenting with dyspnea due to interstitial fibrosis syndrome.
- pulmonary edema due to any cause.
Key exclusion criteria (4 listed)
- Traumatic lesions
- Pneumothorax
- Subcutaneous emphysema
- Massive pleural effusion with atelectasis, and
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 |
|---|---|---|
| High resolution computed tomographyHigh resolution computed tomography of the chest is the gold standard imaging modality for most pulmonary diseases | Other | High Resolution computed tomography |
| trans thoracic ultrasonographyTrans thoracic ultrasonograghy is used progressively for evaluation of pulmonary diseases . Its non invasive nature , relatively low price ,portability for bedside use, and high reproducible of results allows for incorporation of imaging findings with clinical data | Other | High Resolution computed tomography |
Primary outcome
the number of patients diagnosed with pleural diseases by high resolution computed tomography
Time frame: 30 minutes
computed tomography on the chest
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2017.
- Background: PubMed 21160921Sartori S, Tombesi P. Emerging roles for transthoracic ultrasonography in pleuropulmonary pathology. World J Radiol. 2010 Feb 28;2(2):83-90. doi: 10.4329/wjr.v2.i2.83.
- Background: PubMed 15888804Frenz MB, Mee AS. Diagnostic radiation exposure and cancer risk. Gut. 2005 Jun;54(6):889-90. doi: 10.1136/gut.2005.066605. No abstract available.
- Background: PubMed 16984837Volpicelli G, Mussa A, Garofalo G, Cardinale L, Casoli G, Perotto F, Fava C, Frascisco M. Bedside lung ultrasound in the assessment of alveolar-interstitial syndrome. Am J Emerg Med. 2006 Oct;24(6):689-96. doi: 10.1016/j.ajem.2006.02.013.
- Background: PubMed 23937897Smargiassi A, Inchingolo R, Soldati G, Copetti R, Marchetti G, Zanforlin A, Giannuzzi R, Testa A, Nardini S, Valente S. The role of chest ultrasonography in the management of respiratory diseases: document II. Multidiscip Respir Med. 2013 Aug 9;8(1):55. doi: 10.1186/2049-6958-8-55.
- Background: PubMed 25545613Leech M, Bissett B, Kot M, Ntoumenopoulos G. Lung ultrasound for critical care physiotherapists: a narrative review. Physiother Res Int. 2015 Jun;20(2):69-76. doi: 10.1002/pri.1607. Epub 2014 Dec 29.
- Background: PubMed 9372688Lichtenstein D, Meziere G, Biderman P, Gepner A, Barre O. The comet-tail artifact. An ultrasound sign of alveolar-interstitial syndrome. Am J Respir Crit Care Med. 1997 Nov;156(5):1640-6. doi: 10.1164/ajrccm.156.5.96-07096.
- Individual participant dataSharing planned: No
Related trials for Pleural Diseases
RecruitingPhase 1/2
Efficacy and Safety of Ivonescimab Plus Pemetrexed and Platinum-Based Chemotherapy in Advanced Malignant Pleural Mesothelioma
Malignant Pleural Mesothelioma, Advanced
Active, not recruitingPhase 1
Safety and Preliminary Antitumor Activity of Ivonescimab Plus Pemetrexed and Platinum-Based Chemotherapy in Advanced Malignant Pleural Mesothelioma
Malignant Pleural Mesothelioma, Advanced
RecruitingPhase 2
The Diagnostic Accuracy and Clinical Value of FAPI PET in Pleural Mesothelioma
Pleural Mesothelioma, Pleural Diseases
RecruitingPhase 1
SW-682 in Advanced Solid Tumors
Advanced Solid Tumor, Mesothelioma, Malignant
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
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.
Manal Mohamed, MD study director
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing High resolution computed tomography and trans thoracic ultrasonography in people with Pleural Diseases, run by Assiut University.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 1 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gamal Rabeea, MD (00201221729476, gamalagmy135@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the number of patients diagnosed with pleural diseases by high resolution computed tomography (time frame: 30 minutes). 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 NCT03172585, which also lists 6 linked publications.
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 1 Jun 2017.