Breast CancerNCT06695052
Axillary LNs Evalution in Breast Cancer by Multimodal Us
An observational study of Breast Cancer and Lymph Node Metastasis, run by Assiut University.
Trial summary
The present study is designed to evaluate the role of simultaneous multi-modal sonographic tools-Ultrasound (US), Color Doppler Ultrasound (CDU), and Ultrasound Elastography (UE)-in determining the nature (benign or malignant) of axillary lymph nodes (ALNs) in patients with primary breast cancer. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer, Lymph Node Metastasis
- What is being tested?
- multi modal Us
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 20 Nov 2024to 30 Dec 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Female patients with primary breast cancer and metastatic axillary LNs
Who may be able to join
- Patients with primary breast cancer (BrCa) and axillary lymph nodes (ALNs) referred to the Department of Diagnostic Radiology for pre-operative assessment of presence, extent and nature of ALNs.
Who cannot join
- Patients with secondary or recurrent Breast Ca
- Patients exposed to loco-regional radio- or chemotherapy
- Patients with previous axilla surgery
- ± Patients with confirmed metastatic tumor to bone, liver and/or lungs
- Patients who deny or refuse to participate in the study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: "Axillary Nodal Evaluation in Breast Cancer by Multimodal US"
The present study is designed to evaluate the role of simultaneous multi-modal sonographic tools-Ultrasound (US), Color Doppler Ultrasound (CDU), and Ultrasound Elastography (UE)-in determining the nature (benign or malignant) of axillary lymph nodes (ALNs) in patients with primary breast cancer. It aims to compare the diagnostic indices of each modality individually against their combined performance. Specifically, the study will assess whether adding UE to conventional gray-scale US and CDU improves diagnostic accuracy.
Read the detailed description
Breast cancer (BrCa) is the most common malignant tumor affecting women globally, with its incidence and cancer-related mortality rates continuing to rise. Accurate evaluation of the presence, extent, and status of ALNs is critical for prognosis, disease staging, and treatment planning in patients with breast cancer.
Historically, axillary lymph node dissection (ALND), followed by histopathological evaluation, was the standard method for staging breast cancer. However, ALND is associated with short- and long-term complications such as lymphedema, nerve injury, seroma formation, and infection. To reduce these risks, sentinel lymph node biopsy (SLNB) has largely replaced ALND. While SLNB is less invasive and has fewer complications, it is still associated with a risk of false-negative results. According to the American Society of Oncology Guidelines, if SLNB results are negative, no further ALND is performed, as it does not confer a survival benefit. Patients with positive SLNB results, however, undergo a "completion" ALND.
Role of Ultrasound and Color Doppler Ultrasound:
Gray-scale ultrasound (US) is a non-invasive imaging modality widely used for the preoperative evaluation of ALNs in breast cancer patients. It provides valuable morphological information and facilitates obtaining tissue samples. However, its diagnostic accuracy is operator-dependent and limited to structural features of the lymph nodes. Adding Color Doppler Ultrasound (CDU) enhances this evaluation by providing functional insights, such as assessing vascular patterns and calculating the resistive index (RI) of ALNs. Despite their potential, US and CDU exhibit highly variable sensitivity and specificity across studies, which limits their standalone diagnostic utility.
Role of Ultrasound Elastography (UE):
Real-time strain ultrasound elastography (UE) is an advanced imaging technique that measures tissue stiffness, a property often associated with malignancy. Unlike US and CDU, UE can quantify stiffness, providing additional diagnostic insights. Elastography utilizes rhythmic manual compression to produce color-coded elastograms, which display differences in tissue stiffness. These elastograms are generated alongside conventional gray-scale US to ensure precise imaging of the same lymph node. Although UE has been explored for ALN assessment, existing studies report inconsistent results.
Recent meta-analyses suggest that UE offers valuable supplementary information for preoperative ALN evaluation and may influence surgical decision-making.
Other Imaging Modalities:
Alternative imaging techniques, including mammography, magnetic resonance imaging (MRI), multi-detector computed tomography (CT), and positron-emission tomography (PET-CT), have also been employed for ALN assessment. However, their widespread application is limited by moderate sensitivity, low specificity, high costs, radiation exposure, and the need for specialized imaging protocols for ALNs.
Multimodal Imaging:
Multimodal imaging, which combines two or more imaging techniques, provides a more comprehensive diagnostic approach than individual modalities alone. This study investigates the combined use of gray-scale US, CDU, and UE to improve diagnostic accuracy for ALN assessment in breast cancer patients.
This version addresses the study's purpose, methodology, and the role of each modality in greater detail
- Conditions
- Breast Cancer, Lymph Node Metastasis
- Being tested
- multi modal Us
- Keywords
- breast cancer, Lymph Node Metastasis, multimodal ultrasound
- Medical subject headings
- Breast Neoplasms, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multi modal UsDevice
Greyscale US: grey scale ultrasound Color Doppler US: Color Doppler ultrasound Elastography US: Elastography ultrasound
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of axillary LNs in Breast Cancer by Grey Scale Ultrasound
Evaluate axillary lymph nodes (LNs) in breast cancer patients using grey scale ultrasound to assess specific characteristics such as size, shape, and cortical thickening. Results will be compared to Fine Needle Aspiration Cytology (FNAC) or histopathology findings.
Measured: Baseline
Evaluation of axillary LNs in Breast Cancer by Color Doppler Ultrasound
Evaluate axillary lymph nodes (LNs) in breast cancer patients using color Doppler ultrasound to assess vascularity patterns. Results will be compared to FNAC or histopathology findings.
Measured: Baseline
Evaluation of axillary LNs in Breast Cancer by Elastography Ultrasound
Evaluate axillary lymph nodes (LNs) in breast cancer patients using elastography ultrasound to measure stiffness and elasticity. Results will be compared to FNAC or histopathology findings.
Measured: Baseline
Comparison of Multimodal Ultrasound Findings with Histopathology Results
Compare the findings from grey scale ultrasound, color Doppler ultrasound, and elastography ultrasound with histopathology results to assess diagnostic accuracy for evaluating axillary lymph nodes in breast cancer.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start20 Nov 2024 (estimated)
- Primary completion20 Nov 2026 (estimated)
- Study completion30 Dec 2026 (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 CancerStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Abo Elmakarem Ahmed, Assiut University
- Investigators
- Abul Hassan H Mohammed, AP.radiology, Study director, Assiut UniversitySara M Ahmed, AP.radiology, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06695052
- Sponsor's protocol ID
- Axillary LNs in BC by multi US
- Status last verified
- Nov 2024
- First submitted
- 5 Nov 2024
- Last updated
- 19 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tsai WC, Lin CK, Wei HK, Yu BL, Hung CF, Cheng SH, Chen CM. Sonographic elastography improves the sensitivity and specificity of axilla sampling in breast cancer: a prospective study. Ultrasound Med Biol. 2013 Jun;39(6):941-9. doi: 10.1016/j.ultrasmedbio.2012.12.013. Epub 2013 Mar 7.
PubMed 23465139DeSantis CE, Ma J, Gaudet MM, Newman LA, Miller KD, Goding Sauer A, Jemal A, Siegel RL. Breast cancer statistics, 2019. CA Cancer J Clin. 2019 Nov;69(6):438-451. doi: 10.3322/caac.21583. Epub 2019 Oct 2.
PubMed 31577379
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Axillary Nodal Evaluation in Breast Cancer by Multimodal US"
- ClinicalTrials.gov ID
- NCT06695052
- Acronym / sponsor ID
- Axillary LNs in BC by multi US
- Conditions
- Breast Cancer, Lymph Node Metastasis
- Keywords
- breast cancer, Lymph Node Metastasis, multimodal ultrasound
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Nov 2024 (estimated)
- Primary completion
- 20 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 19 Nov 2024 (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 present study is designed to evaluate the role of simultaneous multi-modal sonographic tools-Ultrasound (US), Color Doppler Ultrasound (CDU), and Ultrasound Elastography (UE)-in determining the nature (benign or malignant) of axillary lymph nodes (ALNs) in patients with primary breast cancer. It aims to compare the diagnostic indices of each modality individually against their combined performance. Specifically, the study will assess whether adding UE to conventional gray-scale US and CDU improves diagnostic accuracy.
Detailed description
Breast cancer (BrCa) is the most common malignant tumor affecting women globally, with its incidence and cancer-related mortality rates continuing to rise. Accurate evaluation of the presence, extent, and status of ALNs is critical for prognosis, disease staging, and treatment planning in patients with breast cancer.
Historically, axillary lymph node dissection (ALND), followed by histopathological evaluation, was the standard method for staging breast cancer. However, ALND is associated with short- and long-term complications such as lymphedema, nerve injury, seroma formation, and infection. To reduce these risks, sentinel lymph node biopsy (SLNB) has largely replaced ALND. While SLNB is less invasive and has fewer complications, it is still associated with a risk of false-negative results. According to the American Society of Oncology Guidelines, if SLNB results are negative, no further ALND is performed, as it does not confer a survival benefit. Patients with positive SLNB results, however, undergo a "completion" ALND.
Role of Ultrasound and Color Doppler Ultrasound:
Gray-scale ultrasound (US) is a non-invasive imaging modality widely used for the preoperative evaluation of ALNs in breast cancer patients. It provides valuable morphological information and facilitates obtaining tissue samples. However, its diagnostic accuracy is operator-dependent and limited to structural features of the lymph nodes. Adding Color Doppler Ultrasound (CDU) enhances this evaluation by providing functional insights, such as assessing vascular patterns and calculating the resistive index (RI) of ALNs. Despite their potential, US and CDU exhibit highly variable sensitivity and specificity across studies, which limits their standalone diagnostic utility.
Role of Ultrasound Elastography (UE):
Real-time strain ultrasound elastography (UE) is an advanced imaging technique that measures tissue stiffness, a property often associated with malignancy. Unlike US and CDU, UE can quantify stiffness, providing additional diagnostic insights. Elastography utilizes rhythmic manual compression to produce color-coded elastograms, which display differences in tissue stiffness. These elastograms are generated alongside conventional gray-scale US to ensure precise imaging of the same lymph node. Although UE has been explored for ALN assessment, existing studies report inconsistent results.
Recent meta-analyses suggest that UE offers valuable supplementary information for preoperative ALN evaluation and may influence surgical decision-making.
Other Imaging Modalities:
Alternative imaging techniques, including mammography, magnetic resonance imaging (MRI), multi-detector computed tomography (CT), and positron-emission tomography (PET-CT), have also been employed for ALN assessment. However, their widespread application is limited by moderate sensitivity, low specificity, high costs, radiation exposure, and the need for specialized imaging protocols for ALNs.
Multimodal Imaging:
Multimodal imaging, which combines two or more imaging techniques, provides a more comprehensive diagnostic approach than individual modalities alone. This study investigates the combined use of gray-scale US, CDU, and UE to improve diagnostic accuracy for ALN assessment in breast cancer patients.
This version addresses the study's purpose, methodology, and the role of each modality in greater detail
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Female patients with primary breast cancer and metastatic axillary LNs
Key inclusion criteria (1 listed)
- Patients with primary breast cancer (BrCa) and axillary lymph nodes (ALNs) referred to the Department of Diagnostic Radiology for pre-operative assessment of presence, extent and nature of ALNs.
Key exclusion criteria (5 listed)
- Patients with secondary or recurrent Breast Ca
- Patients exposed to loco-regional radio- or chemotherapy
- Patients with previous axilla surgery
- ± Patients with confirmed metastatic tumor to bone, liver and/or lungs
- Patients who deny or refuse to participate in the study
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 |
|---|---|---|
| multi modal UsGreyscale US: grey scale ultrasound Color Doppler US: Color Doppler ultrasound Elastography US: Elastography ultrasound | Device | – |
Primary outcome
Evaluation of axillary LNs in Breast Cancer by Grey Scale Ultrasound
Time frame: Baseline
Evaluate axillary lymph nodes (LNs) in breast cancer patients using grey scale ultrasound to assess specific characteristics such as size, shape, and cortical thickening. Results will be compared to Fine Needle Aspiration Cytology (FNAC) or histopathology findings.
Evaluation of axillary LNs in Breast Cancer by Color Doppler Ultrasound
Time frame: Baseline
Evaluate axillary lymph nodes (LNs) in breast cancer patients using color Doppler ultrasound to assess vascularity patterns. Results will be compared to FNAC or histopathology findings.
Evaluation of axillary LNs in Breast Cancer by Elastography Ultrasound
Time frame: Baseline
Evaluate axillary lymph nodes (LNs) in breast cancer patients using elastography ultrasound to measure stiffness and elasticity. Results will be compared to FNAC or histopathology findings.
Comparison of Multimodal Ultrasound Findings with Histopathology Results
Time frame: Baseline
Compare the findings from grey scale ultrasound, color Doppler ultrasound, and elastography ultrasound with histopathology results to assess diagnostic accuracy for evaluating axillary lymph nodes in breast cancer.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Background: PubMed 23465139Tsai WC, Lin CK, Wei HK, Yu BL, Hung CF, Cheng SH, Chen CM. Sonographic elastography improves the sensitivity and specificity of axilla sampling in breast cancer: a prospective study. Ultrasound Med Biol. 2013 Jun;39(6):941-9. doi: 10.1016/j.ultrasmedbio.2012.12.013. Epub 2013 Mar 7.
- Background: PubMed 31577379DeSantis CE, Ma J, Gaudet MM, Newman LA, Miller KD, Goding Sauer A, Jemal A, Siegel RL. Breast cancer statistics, 2019. CA Cancer J Clin. 2019 Nov;69(6):438-451. doi: 10.3322/caac.21583. Epub 2019 Oct 2.
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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.
Abul Hassan H Mohammed, AP.radiology study director
Assiut University
Sara M Ahmed, AP.radiology study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Lymph Node Metastasis, 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 5 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: opening soon, as of the sponsor's last update on 19 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heba Abo EM Ahmed, AL.Radiology (+01122112561, hoobamakarem@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of axillary LNs in Breast Cancer by Grey Scale Ultrasound (time frame: Baseline). The study lists 4 primary outcomes in all. 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 NCT06695052, 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 19 Nov 2024.