Ultrasound Therapy; ComplicationsNCT05692141
The Value of Ultrasound Elastography for Differentiating Benign and Malignant Superficial Soft Tissue Masses
An observational study of Ultrasound Therapy; Complications, run by Assiut University.
Trial summary
Ultrasonography has the advantages of being widely available, cost-effective, and allowing real-time dynamic examinations. Additionally, it is less time-consuming than magnetic resonance imaging (MRI) [1,2]. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ultrasound Therapy; Complications
- What is being tested?
- ultrasound
- Type of treatment
- Medical device
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2023to 30 Dec 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study will analyze patients who receive care at our institution patients with soft tissue masses. We retrospectively investigate patients' medical records, ultrasonographic exams, and histopathology reports
Who may be able to join
- patients with superficial masses
Who cannot join
- inflammatory lesions
Trial locations and contacts
No sites are listed yet.
About this study
Ultrasonography has the advantages of being widely available, cost-effective, and allowing real-time dynamic examinations. Additionally, it is less time-consuming than magnetic resonance imaging (MRI) [1,2]. Recently developed ultrasound elastography techniques provide valuable information about intrinsic tissue properties by evaluating tissue elasticity, which may contribute to the diagnosis [3,4]. Ultrasound elastography can quantify and qualify tissue elasticity and add important information to the findings obtained by conventional ultrasonography [3,5-7]. Superficial soft tissue masses frequently occur and primarily manifest as benign lesions (including lipoma and hemangioma) that typically do not require treatment. Although malignant masses are rare, prompt surgical resections are required following the confirmation of a diagnosis (8). Therefore, differentiating between benign and malignant masses is important to prevent delays in the treatment of the malignant masses and avoid unnecessary surgical treatments for the benign masses (9). As the most effective method, pathological diagnosis is typically obtained from a needle biopsy. However, it is an invasive maneuver that is uncomfortable for patients and impractical for all types of soft tissue masses (10). Ultrasound is the primary examination method for superficial soft tissue masses to confirm their size, location, and the association between the masses and the surrounding structures. Through observations of the borders of the tissue masses, internal echo characteristics, and internal blood flow signals, ultrasounds may provide a preliminary diagnosis that is inaccurate (11). Stiffness of the tissue structures may be accessed using ultrasound elastography (UE) (12), which is an effective tool for differentiating malignant and benign masses (13). The stiffness of a malignant tumor is typically higher compared with a benign tumor. Previously, the differential diagnosis was primarily based on palpations by the physicians, which was indirect and could be limited in patients with obesity, mass sizes and depths, and physicians' experiences.
Read the detailed description
The diagnostic imaging workup of soft tissue lesions begins with ultrasound and magnetic resonance imaging (MRI). In cases where the imaging features are not typical for a specific lesion (such as lipoma or ganglion cyst), imaging is insufficient to provide a definitive diagnosis, and these patients ultimately require a tissue sample by a percutaneous or excisional biopsy to guide further management.
In ultrasound, an emerging technology is an elastography which provides information on the stiffness of tissues. There are two main techniques, namely, strain elastography and shear wave elastography. In strain, or compression elastography, a force is applied to the tissues from the transducer by repetitive manual pressure, and the displacement (strain) is calculated from the return velocities of the tissues with respect to time. This creates a qualitative (color-coded) map of the elastic properties of the tissues. In shear wave elastography, vibration is applied to the tissues through a focussed ultrasound pulse, creating transverse shear waves in the tissues, the velocities of which can then be measured. Thus, shear wave elastography is a quantitative technique .
Patient selection This study will analyze patients who receive care at our institution patients with soft tissue masses. We retrospectively investigate patients' medical records, ultrasonographic exams, and histopathology reports Ultrasonographic Examination For each lesion, ultrasound Elastography would be performed using a Linear probe ; In Strain Elastography: Colors of the images represent different strain rates in decreasing order from red to green to blue. Based on the image colors, tissue elasticity was classified into 4 scores representing different stiffness: * score 1: completely red or green, * score 2: blue and green, with green as the dominant color, * score 3: blue and green, with blue as the dominant color, *score 4: completely blue. Strain rates of samples inside and outside the masses are measured to calculate the strain ratios (SRs).
In Shear Wave Elastography: The transducer is perpendicular to the lesion and stationary, without external compression. Grayscale images and color-coded histograms would be displayed with dual-mode imaging in real-time. In the chromatic scale, red indicates a higher shear modulus than blue. Several circular regions of interest (ROIs) with a diameter of 2 or 3 mm are placed within the lesion. The mean shear modulus for each ROI is measured automatically. We calculate the median value of several mean shear moduli corresponding to the ROIs, and this value is defined as the median shear modulus of the lesion. The unit of shear modulus values is the kilopascal (kPa)
- Conditions
- Ultrasound Therapy; Complications
- Being tested
- ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundDevice
For each lesion, ultrasound Elastography would be performed using a Linear probe ;
What is being measured
The primary outcome is the main question the study is designed to answer.
to investigate the value of ultrasound Elastography for differentiating benign and malignant superficial soft tissue masses .
to investigate the value of ultrasound Elastography for differentiating benign and malignant superficial soft tissue masses .
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start1 Feb 2023 (estimated)
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2024 (estimated)
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 Ultrasound Therapy; ComplicationsStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aliaa Sayed Ali Hassan, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05692141
- Sponsor's protocol ID
- elastography
- Status last verified
- Jan 2023
- First submitted
- 11 Jan 2023
- Last updated
- 20 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yeoh HJ, Kim TY, Ryu JA. The feasibility of shear wave elastography for diagnosing superficial benign soft tissue masses. Ultrasonography. 2019 Jan;38(1):37-43. doi: 10.14366/usg.17059. Epub 2018 Jan 19.
PubMed 29580047
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Ultrasound Elastography for Differentiating Benign and Malignant Superficial Soft Tissue Masses
- ClinicalTrials.gov ID
- NCT05692141
- Acronym / sponsor ID
- elastography
- Conditions
- Ultrasound Therapy; Complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 20 Jan 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.
Ultrasonography has the advantages of being widely available, cost-effective, and allowing real-time dynamic examinations. Additionally, it is less time-consuming than magnetic resonance imaging (MRI) [1,2]. Recently developed ultrasound elastography techniques provide valuable information about intrinsic tissue properties by evaluating tissue elasticity, which may contribute to the diagnosis [3,4]. Ultrasound elastography can quantify and qualify tissue elasticity and add important information to the findings obtained by conventional ultrasonography [3,5-7]. Superficial soft tissue masses frequently occur and primarily manifest as benign lesions (including lipoma and hemangioma) that typically do not require treatment. Although malignant masses are rare, prompt surgical resections are required following the confirmation of a diagnosis (8). Therefore, differentiating between benign and malignant masses is important to prevent delays in the treatment of the malignant masses and avoid unnecessary surgical treatments for the benign masses (9). As the most effective method, pathological diagnosis is typically obtained from a needle biopsy. However, it is an invasive maneuver that is uncomfortable for patients and impractical for all types of soft tissue masses (10). Ultrasound is the primary examination method for superficial soft tissue masses to confirm their size, location, and the association between the masses and the surrounding structures. Through observations of the borders of the tissue masses, internal echo characteristics, and internal blood flow signals, ultrasounds may provide a preliminary diagnosis that is inaccurate (11). Stiffness of the tissue structures may be accessed using ultrasound elastography (UE) (12), which is an effective tool for differentiating malignant and benign masses (13). The stiffness of a malignant tumor is typically higher compared with a benign tumor. Previously, the differential diagnosis was primarily based on palpations by the physicians, which was indirect and could be limited in patients with obesity, mass sizes and depths, and physicians' experiences.
Detailed description
The diagnostic imaging workup of soft tissue lesions begins with ultrasound and magnetic resonance imaging (MRI). In cases where the imaging features are not typical for a specific lesion (such as lipoma or ganglion cyst), imaging is insufficient to provide a definitive diagnosis, and these patients ultimately require a tissue sample by a percutaneous or excisional biopsy to guide further management.
In ultrasound, an emerging technology is an elastography which provides information on the stiffness of tissues. There are two main techniques, namely, strain elastography and shear wave elastography. In strain, or compression elastography, a force is applied to the tissues from the transducer by repetitive manual pressure, and the displacement (strain) is calculated from the return velocities of the tissues with respect to time. This creates a qualitative (color-coded) map of the elastic properties of the tissues. In shear wave elastography, vibration is applied to the tissues through a focussed ultrasound pulse, creating transverse shear waves in the tissues, the velocities of which can then be measured. Thus, shear wave elastography is a quantitative technique .
Patient selection This study will analyze patients who receive care at our institution patients with soft tissue masses. We retrospectively investigate patients' medical records, ultrasonographic exams, and histopathology reports Ultrasonographic Examination For each lesion, ultrasound Elastography would be performed using a Linear probe ; In Strain Elastography: Colors of the images represent different strain rates in decreasing order from red to green to blue. Based on the image colors, tissue elasticity was classified into 4 scores representing different stiffness: * score 1: completely red or green, * score 2: blue and green, with green as the dominant color, * score 3: blue and green, with blue as the dominant color, *score 4: completely blue. Strain rates of samples inside and outside the masses are measured to calculate the strain ratios (SRs).
In Shear Wave Elastography: The transducer is perpendicular to the lesion and stationary, without external compression. Grayscale images and color-coded histograms would be displayed with dual-mode imaging in real-time. In the chromatic scale, red indicates a higher shear modulus than blue. Several circular regions of interest (ROIs) with a diameter of 2 or 3 mm are placed within the lesion. The mean shear modulus for each ROI is measured automatically. We calculate the median value of several mean shear moduli corresponding to the ROIs, and this value is defined as the median shear modulus of the lesion. The unit of shear modulus values is the kilopascal (kPa)
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study will analyze patients who receive care at our institution patients with soft tissue masses. We retrospectively investigate patients' medical records, ultrasonographic exams, and histopathology reports
Key inclusion criteria (1 listed)
- patients with superficial masses
Key exclusion criteria (1 listed)
- inflammatory lesions
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 |
|---|---|---|
| ultrasoundFor each lesion, ultrasound Elastography would be performed using a Linear probe ; | Device | – |
Primary outcome
to investigate the value of ultrasound Elastography for differentiating benign and malignant superficial soft tissue masses .
Time frame: baseline
to investigate the value of ultrasound Elastography for differentiating benign and malignant superficial soft tissue masses .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
- Background: PubMed 29580047Yeoh HJ, Kim TY, Ryu JA. The feasibility of shear wave elastography for diagnosing superficial benign soft tissue masses. Ultrasonography. 2019 Jan;38(1):37-43. doi: 10.14366/usg.17059. Epub 2018 Jan 19.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Ultrasound Therapy; Complications, 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 1 inclusion and 1 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 20 Jan 2023. 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 Aliaa Sayed, Resident (01094367328, hadeersayed2211@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to investigate the value of ultrasound Elastography for differentiating benign and malignant superficial soft tissue masses . (time frame: baseline). 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 NCT05692141, 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 20 Jan 2023.