Peripheral Lung LesionsNCT05752227
Difference Strain Ratio Ultrasound Elastography Between Benign and Malignant Peripheral Lung Lesions
An observational study of Peripheral Lung Lesions, run by Alexandria University at 1 site in Egypt.
Trial summary
Diagnostic accuracy study to investigate the sensitivity and specificity of sonographic elastography using strain ratio to differentiate between benign and malignant peripheral lesions in comparison to biopsy, clinically, or radiologically. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peripheral Lung Lesions
- What is being tested?
- Transthoracic biopsy and CT chest
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2022to Mar 2023
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients are all above age of 18 yrs old without gender discrimination
Who may be able to join
- 1) Adult patients above age of 18 years old. 2) Patients with peripheral lung lesion.
Who cannot join
- Pure pleural lesions.
- Clinical instability to reach the final diagnosis.
- Inaccessibility by ultrasound.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ahmed Farag Abouelnour
Alexandria, 00203
Ahmed Abouelnour, 01111609023, abouelnourahmed@gmail.com
About this study
Official title: Difference In Strain Ratio Ultrasound Elastography Between Benign And Malignant Peripheral Parenchymal Lung Lesions.
Diagnostic accuracy study to investigate the sensitivity and specificity of sonographic elastography using strain ratio to differentiate between benign and malignant peripheral lesions in comparison to biopsy, clinically, or radiologically.
Read the detailed description
This is a diagnostic accuracy study with comparison to gold standard tests e.g., chest computed tomography, transthoracic biopsy, or microbiological analysis. All patients included in this study will give informed consent according to the guidelines of ethics committee, Alexandria Faculty of Medicine. (http://www.med.alexu.edu.eg/wp-content/uploads/2012/04/Checklist-FINAL- 20141.pdf-)
- Conditions
- Peripheral Lung Lesions
- Being tested
- Transthoracic biopsy, CT chest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transthoracic biopsyProcedure or surgery
Us guided transthoracic biopsy
CT chestRadiation
Computed tomography
| Study group | Role | What they receive |
|---|---|---|
| benign lung lesions | Patient who were diagnosed with peripheral lung lesions including consolidation, atelectasis, or cavitation Receives: Procedure: Transthoracic biopsy; Radiation: CT chest | |
| malignant lung lesions | patients diagnosed with malignant lung lesions Receives: Procedure: Transthoracic biopsy; Radiation: CT chest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cut off value strain ratio
To differentiate between benign and malignant lung lesions using strain ratio
Measured: 6-9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start1 Jun 2022
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Lung LesionsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmed F Abouelnour, Masters, Principal investigator, Alexandrian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05752227
- Sponsor's protocol ID
- 0201692
- Status last verified
- Nov 2022
- First submitted
- 23 Dec 2022
- Last updated
- 2 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol and full methodology of our study to be shared
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Difference In Strain Ratio Ultrasound Elastography Between Benign And Malignant Peripheral Parenchymal Lung Lesions.
- ClinicalTrials.gov ID
- NCT05752227
- Acronym / sponsor ID
- 0201692
- Conditions
- Peripheral Lung Lesions
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 2 Mar 2023 (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.
Diagnostic accuracy study to investigate the sensitivity and specificity of sonographic elastography using strain ratio to differentiate between benign and malignant peripheral lesions in comparison to biopsy, clinically, or radiologically.
Detailed description
This is a diagnostic accuracy study with comparison to gold standard tests e.g., chest computed tomography, transthoracic biopsy, or microbiological analysis. All patients included in this study will give informed consent according to the guidelines of ethics committee, Alexandria Faculty of Medicine. (http://www.med.alexu.edu.eg/wp-content/uploads/2012/04/Checklist-FINAL- 20141.pdf-)
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| benign lung lesions | – | Procedure: Transthoracic biopsy, Radiation: CT chestPatient who were diagnosed with peripheral lung lesions including consolidation, atelectasis, or cavitation |
| malignant lung lesions | – | Procedure: Transthoracic biopsy, Radiation: CT chestpatients diagnosed with malignant lung lesions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients are all above age of 18 yrs old without gender discrimination
Key inclusion criteria (1 listed)
- 1) Adult patients above age of 18 years old. 2) Patients with peripheral lung lesion.
Key exclusion criteria (3 listed)
- Pure pleural lesions.
- Clinical instability to reach the final diagnosis.
- Inaccessibility by ultrasound.
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 |
|---|---|---|
| Transthoracic biopsyUs guided transthoracic biopsy | Procedure or surgery | benign lung lesions, malignant lung lesions |
| CT chestComputed tomography | Radiation | benign lung lesions, malignant lung lesions |
Primary outcome
Cut off value strain ratio
Time frame: 6-9 months
To differentiate between benign and malignant lung lesions using strain ratio
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- Individual participant dataSharing planned: Yes. Study protocol and full methodology of our study to be shared
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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.
Ahmed F Abouelnour, Masters principal investigator
Alexandrian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Lung Lesions, run by Alexandria University at 1 site in Egypt.
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 1 inclusion and 3 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 2 Mar 2023. 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 Egypt. 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.
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 Ahmed F Abouelnour (01111609023, abouelnourahmed@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cut off value strain ratio (time frame: 6-9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Mar 2023.