Breast Lump (Malignant)NCT04574531
us Elastography and us Doppler in Differentiating Breast Masses
An observational study of Breast Lump (Malignant), run by Assiut University.
Trial summary
The aim of this study is to compare the diagnostic performance of grey scale US , US elastography \& color Doppler US in differentiating breast masses comparable with histopathology as a gold standard. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Lump (Malignant)
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Sep 2021to Dec 2022
- 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
- No healthy volunteers
- Adult, Older adult
Study population: All patients will subjected to : Full history taking, clinical examination by referring physician . Then the patient will be examined by Gray scale US , doppler and elastography at Radiology department. On Gray scale:Echogenicity of the mass with respect to normal breast parenchyma, diameter A/T ,margins and calcifications. While on Color Doppler, to describe the vascular patterns. Masses and axillary lymph nodes (if detected) will be identified as nonvascular or vascular (peripheral, central, or mix). (A) Strain elastography Color coding is classified into 5 groups according to the Ueno classification, score one (softest component) and score five (hardest component) . (B) Shear wave elastography A ROI rectangular box was adjusted on the observed target lesion including sufficient amount of surrounding healthy breast tissue.
Who may be able to join
- patients with breast masses referred to our department of diagnostic radiology for radiological assessment.
Who cannot join
- Patients with purely cystic lesions on conventional breast ultrasound. Breast implant. Superficial lesions (>5 mm deep to skin surface).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparative Study of US Elastography and Color Doppler US in Differentiating Breast Masses in Correlation to Histopathology
The aim of this study is to compare the diagnostic performance of grey scale US , US elastography \& color Doppler US in differentiating breast masses comparable with histopathology as a gold standard.
Read the detailed description
Breast cancer is the most fre¬quently diagnosed cancer and the chief cause of cancer death among women worldwide, with an es¬timated 1.7 million cases.
Breast cancer alone accounts for 25% of all cancer cases and 15% of all cancer deaths among females .so, Its high incidence has led to research on new diagnostic imaging techniques for early diagnosis and to improve patient's mortality rate[1].
Application of imaging techniques together with other investigation would help clinical decision making. the most important factor in reducing mortality of certain cancers is an early diagnosis of cancer via screening based on imaging[2].
US is an accurate method for detection of breast masses ; however, US has a low accuracy in differentiating between benign from malignant breast masses . US could suggest a malignancy likelihood criteria of a breast mass, such as hypoechogenicity, irregular margins, microcalcifications, increased vascularity by Doppler and us elastography [3].
Ultrasound elastography provides a non-invasive evaluation of the "stiffness" of a lesion. Recent studies show that ultrasonographic elastogra¬phy (USE) provides higher diagnostic accuracy together with Doppler application compared with conventional B-mode ultrasonography during breast cancer diagnosis, which eventually helps to reduce false-positive results (ie, increased specificity) and therefore is useful in avoiding breast biopsy[4].
US elastography has been used to detect the nature of breast lesions , by measuring the tissue stiffness non invasively. It depends on tissue deformation strain that is caused by external compression. it is complementary to gray scale findings particularly in lesions with indeterminate US findings, also US elastography could be used to guide the follow up of leisons diagnosed as benign at ( FNA) fine needle aspiration.[5][6]
- Conditions
- Breast Lump (Malignant)
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison between us elastography and doppler us of breast masses with the histopathology of the specimens
comparitive study between us elastography and doppler us of breast masses in differentiating breast 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 posted5 Oct 2020
- Study startSep 2021 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast Lump (Malignant)Studies 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
- Other
- Time perspective
- Other
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Sayed Mohamed Abd Elsamie, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04574531
- Sponsor's protocol ID
- breast US elastography
- Status last verified
- Sep 2020
- First submitted
- 29 Sep 2020
- Last updated
- 5 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sigrist RMS, Liau J, Kaffas AE, Chammas MC, Willmann JK. Ultrasound Elastography: Review of Techniques and Clinical Applications. Theranostics. 2017 Mar 7;7(5):1303-1329. doi: 10.7150/thno.18650. eCollection 2017.
PubMed 28435467Barr RG. Breast Elastography: How to Perform and Integrate Into a "Best-Practice" Patient Treatment Algorithm. J Ultrasound Med. 2020 Jan;39(1):7-17. doi: 10.1002/jum.15137. Epub 2019 Oct 16.
PubMed 31617225
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of US Elastography and Color Doppler US in Differentiating Breast Masses in Correlation to Histopathology
- ClinicalTrials.gov ID
- NCT04574531
- Acronym / sponsor ID
- breast US elastography
- Conditions
- Breast Lump (Malignant)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2021 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 5 Oct 2020 (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.
The aim of this study is to compare the diagnostic performance of grey scale US , US elastography \& color Doppler US in differentiating breast masses comparable with histopathology as a gold standard.
Detailed description
Breast cancer is the most fre¬quently diagnosed cancer and the chief cause of cancer death among women worldwide, with an es¬timated 1.7 million cases.
Breast cancer alone accounts for 25% of all cancer cases and 15% of all cancer deaths among females .so, Its high incidence has led to research on new diagnostic imaging techniques for early diagnosis and to improve patient's mortality rate[1].
Application of imaging techniques together with other investigation would help clinical decision making. the most important factor in reducing mortality of certain cancers is an early diagnosis of cancer via screening based on imaging[2].
US is an accurate method for detection of breast masses ; however, US has a low accuracy in differentiating between benign from malignant breast masses . US could suggest a malignancy likelihood criteria of a breast mass, such as hypoechogenicity, irregular margins, microcalcifications, increased vascularity by Doppler and us elastography [3].
Ultrasound elastography provides a non-invasive evaluation of the "stiffness" of a lesion. Recent studies show that ultrasonographic elastogra¬phy (USE) provides higher diagnostic accuracy together with Doppler application compared with conventional B-mode ultrasonography during breast cancer diagnosis, which eventually helps to reduce false-positive results (ie, increased specificity) and therefore is useful in avoiding breast biopsy[4].
US elastography has been used to detect the nature of breast lesions , by measuring the tissue stiffness non invasively. It depends on tissue deformation strain that is caused by external compression. it is complementary to gray scale findings particularly in lesions with indeterminate US findings, also US elastography could be used to guide the follow up of leisons diagnosed as benign at ( FNA) fine needle aspiration.[5][6]
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients will subjected to : Full history taking, clinical examination by referring physician . Then the patient will be examined by Gray scale US , doppler and elastography at Radiology department. On Gray scale:Echogenicity of the mass with respect to normal breast parenchyma, diameter A/T ,margins and calcifications. While on Color Doppler, to describe the vascular patterns. Masses and axillary lymph nodes (if detected) will be identified as nonvascular or vascular (peripheral, central, or mix). (A) Strain elastography Color coding is classified into 5 groups according to the Ueno classification, score one (softest component) and score five (hardest component) . (B) Shear wave elastography A ROI rectangular box was adjusted on the observed target lesion including sufficient amount of surrounding healthy breast tissue.
Key inclusion criteria (1 listed)
- patients with breast masses referred to our department of diagnostic radiology for radiological assessment.
Key exclusion criteria (1 listed)
- Patients with purely cystic lesions on conventional breast ultrasound. Breast implant. Superficial lesions (>5 mm deep to skin surface).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
comparison between us elastography and doppler us of breast masses with the histopathology of the specimens
Time frame: baseline
comparitive study between us elastography and doppler us of breast masses in differentiating breast masses
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
- Background: PubMed 28435467Sigrist RMS, Liau J, Kaffas AE, Chammas MC, Willmann JK. Ultrasound Elastography: Review of Techniques and Clinical Applications. Theranostics. 2017 Mar 7;7(5):1303-1329. doi: 10.7150/thno.18650. eCollection 2017.
- Background: PubMed 31617225Barr RG. Breast Elastography: How to Perform and Integrate Into a "Best-Practice" Patient Treatment Algorithm. J Ultrasound Med. 2020 Jan;39(1):7-17. doi: 10.1002/jum.15137. Epub 2019 Oct 16.
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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 Breast Lump (Malignant), 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 5 Oct 2020. 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 asmaa sayed mohamed abd elsamie (01556663434, asmaasmhmd7@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison between us elastography and doppler us of breast masses with the histopathology of the specimens (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 NCT04574531, which also lists 2 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 5 Oct 2020.