Breast CancerNCT05346510
Prone Positioning CT Scan and Ultrasound Assessing Axillary Lymph Nodes in Patients With Breast Cancer Official Title: Evaluation of Axillary Lymph Nodes Using Prone Positioning Computed Tomography Scan and Ultrasound in Patients With Breast Cancer
A study testing ALND Group in people with Breast Cancer, run by Shengjing Hospital at 1 site in China.
Trial summary
The early diagnosis and evaluation of breast cancer is of great significance to its treatment and prognosis. Among the multiple factors affecting the prognosis, the degree of axillary lymph node metastasis is one of the most vital factors. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- ALND Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2022to 31 Aug 2027
- Phase
- Interventional
- 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 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Preoperative chest CT and axillary Doppler ultrasound examination in the prone position
- Perform ALND
- Regular post surgery follow-up (short-term and long-term)
Who cannot join
- •History of other benign or malignant tumors causing axillary lymphadenopathy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Liaoning Oncology Hospital
Shenyang, Liaoning, 110042
About this study
Official title: Evaluation of Axillary Lymph Nodes Using Prone Positioning Computed Tomography Scan and Ultrasound in Patients With Breast Cancer
The early diagnosis and evaluation of breast cancer is of great significance to its treatment and prognosis. Among the multiple factors affecting the prognosis, the degree of axillary lymph node metastasis is one of the most vital factors.
Accurately understanding the status of axillary lymph nodes prior to surgery allows better prediction of staging, enables correct treatment plans, and guides the scope of node dissection during surgery. For patients with early breast cancer or clinically negative axillary lymph nodes, sentinel lymph node biopsy (SLNB) can largely avoid complications such as upper extremity lymphedema caused by axillary lymph node dissection (ALND). Thus, clinical identification of negative lymph nodes becomes more valuable. Based on clinical verification, the NCCN guidelines (edition 2019) made the following recommendation: SLNB is performed for patients with clinically negative axillary lymph nodes, and the biopsy findings determine whether ALND is included; ALND is performed for patients with clinically positive axillary nodes. Currently, imaging examinations have limitations is assessing axillary lymph nodes. Finding an accurate and non-invasive method in preoperative axillary assessment has been a project that needs to be urgently addressed. Ultrasonography has advantages in its simplicity, non-invasiveness, economy, and on radiation, however it is highly subjective, dependent upon examiner's experience and knowledge, and is difficult to detect deeper and small lesions. Molybdenum Target examination plays an important role in diagnosis of breast cancer, however it is expensive and limited in evaluating the whole axilla. PET-CT is restricted by its high cost and is not a routine examination in China.
Therefore, computed tomography (CT) scan is more advantageous in determination of lymph node metastasis. The 2014 GORO KUTOMI study suggested that lymph node morphology assessed as clear by preoperative CT was an independent predictor of sentinel lymph node metastasis. CT scan can not only evaluate the presence or absence of distant metastasis and pectoralis muscle invasion, but also provide intuitive, accurate and detailed evaluation of axillary, supraclavicular, and pectoralis major intramuscular lymph nodes. The diagnostic criteria of magnetic resonance imaging (MRI) is relatively vague; CT can also obtain imaging data of the lungs, mediastinum, whereas MRI has no such function. Based on previous studies, we will further explore and evaluate axillary node status using prone positioning CT scan and ultrasound in patients with breast cancer.
Read the detailed description
A total of 500 patients who are newly diagnosed with operable breast cancer in Liaoning Oncology Hospital are approached and recruited. Inclusion criteria: 1. preoperative chest CT and axillary Doppler ultrasound examination in the prone position; 2. perform ALND; 3. regular follow-up post surgery, short-term and long-term. Exclusion criteria: history of other benign or malignant tumors causing axillary lymphadenopathy.
Comparisons are made:
A: between suspiciously positive and suspiciously negative axillary lymph nodes B: between LNSD positive among suspiciously positive axillary lymph nodes and negative axillary lymph nodes f C: between positive and negative AAUS D: between positive and negative AAUS among negative lymph nodes detected by CT scan E: between positive and negative AAUS among lymph nodes with negative LNSD
Chi-square test and t test are used to assess statistical significance between groups.
Methods: Lymph node short diameter (LNSD) is measured using CT scan imaging (LNSD > 1cm is considered positive), axillary lymph node status is assessed according to axillary lymph node Doppler ultrasound. ALND will be performed in patients with positive axillary lymph nodes on CT scan; PALND will be performed for those with negative axillary lymph nodes on CT scan but positive on AAUS; SLNB will be performed for those with negative axillary lymph nodes on CT scan and on AAUS.
The prognosis in each patient group is to be evaluated by short-term observational indicators (e.g. lymphedema and/or status of axillary lymphatic return), and long-term indicators (e.g. lymphedema and/or axillary lymph node recurrence). The accuracy of CT scan assessing positive lymph nodes and positive AAUS will be evaluated according to the postoperative histology results.
- Conditions
- Breast Cancer
- Being tested
- ALND Group
- Keywords
- Breast cancer, axillary lymph node, prone positioning computed tomography, ultrasound
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALND GroupProcedure or surgery
Also called pALND Group, SLNB Group
ALND is performed in patients with positive axillary lymph nodes on CT scan and on AAUS. pALND is performed in patients with negative axillary lymph nodes on CT scan but positive on AAUS.SLNB will be performed for those with negative axillary lymph nodes on CT scan and on AAUS.
| Study group | Role | What they receive |
|---|---|---|
| ALND Group | Experimental | ALND is performed in patients with positive axillary lymph nodes on CT scan and on AAUS. Receives: Procedure: ALND Group |
| pALND Group | Experimental | pALND is performed in patients with negative axillary lymph nodes on CT scan but positive on AAUS. Receives: Procedure: ALND Group |
| SLNB Group | Experimental | SLNB will be performed for those with negative axillary lymph nodes on CT scan and on AAUS. Receives: Procedure: ALND Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement rates with postoperative histology
The accuracy of CT scan detecting positive axillary lymph node and positive AAUS is assessed by the postoperative histology results
Measured: Two weeks
Secondary outcomes (2)
The incidence of postoperative lymphedema (short-term observational indicator)
The purpose of SLNB is to reduce the scope of axillary lymph node dissection, therefore reduce the occurrence of complications.
Measured: Two years
Axillary recurrence rate
Axillary recurrence rate as a long-term observational indicator
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start1 Mar 2022
- Primary completion1 Sep 2022 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Shengjing HospitalThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianyi Li, Shengjing Hospital
- Investigators
- Jianyi Li, Dr, Principal investigator, Cancer Hospital of China Medical University, Liaoning Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05346510
- Sponsor's protocol ID
- Shengjing-LJY07
- Status last verified
- Apr 2022
- First submitted
- 19 Apr 2022
- Last updated
- 26 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Axillary Lymph Nodes Using Prone Positioning Computed Tomography Scan and Ultrasound in Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT05346510
- Acronym / sponsor ID
- Shengjing-LJY07
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, axillary lymph node, prone positioning computed tomography, ultrasound
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 26 Apr 2022 (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 early diagnosis and evaluation of breast cancer is of great significance to its treatment and prognosis. Among the multiple factors affecting the prognosis, the degree of axillary lymph node metastasis is one of the most vital factors.
Accurately understanding the status of axillary lymph nodes prior to surgery allows better prediction of staging, enables correct treatment plans, and guides the scope of node dissection during surgery. For patients with early breast cancer or clinically negative axillary lymph nodes, sentinel lymph node biopsy (SLNB) can largely avoid complications such as upper extremity lymphedema caused by axillary lymph node dissection (ALND). Thus, clinical identification of negative lymph nodes becomes more valuable. Based on clinical verification, the NCCN guidelines (edition 2019) made the following recommendation: SLNB is performed for patients with clinically negative axillary lymph nodes, and the biopsy findings determine whether ALND is included; ALND is performed for patients with clinically positive axillary nodes. Currently, imaging examinations have limitations is assessing axillary lymph nodes. Finding an accurate and non-invasive method in preoperative axillary assessment has been a project that needs to be urgently addressed. Ultrasonography has advantages in its simplicity, non-invasiveness, economy, and on radiation, however it is highly subjective, dependent upon examiner's experience and knowledge, and is difficult to detect deeper and small lesions. Molybdenum Target examination plays an important role in diagnosis of breast cancer, however it is expensive and limited in evaluating the whole axilla. PET-CT is restricted by its high cost and is not a routine examination in China.
Therefore, computed tomography (CT) scan is more advantageous in determination of lymph node metastasis. The 2014 GORO KUTOMI study suggested that lymph node morphology assessed as clear by preoperative CT was an independent predictor of sentinel lymph node metastasis. CT scan can not only evaluate the presence or absence of distant metastasis and pectoralis muscle invasion, but also provide intuitive, accurate and detailed evaluation of axillary, supraclavicular, and pectoralis major intramuscular lymph nodes. The diagnostic criteria of magnetic resonance imaging (MRI) is relatively vague; CT can also obtain imaging data of the lungs, mediastinum, whereas MRI has no such function. Based on previous studies, we will further explore and evaluate axillary node status using prone positioning CT scan and ultrasound in patients with breast cancer.
Detailed description
A total of 500 patients who are newly diagnosed with operable breast cancer in Liaoning Oncology Hospital are approached and recruited. Inclusion criteria: 1. preoperative chest CT and axillary Doppler ultrasound examination in the prone position; 2. perform ALND; 3. regular follow-up post surgery, short-term and long-term. Exclusion criteria: history of other benign or malignant tumors causing axillary lymphadenopathy.
Comparisons are made:
A: between suspiciously positive and suspiciously negative axillary lymph nodes B: between LNSD positive among suspiciously positive axillary lymph nodes and negative axillary lymph nodes f C: between positive and negative AAUS D: between positive and negative AAUS among negative lymph nodes detected by CT scan E: between positive and negative AAUS among lymph nodes with negative LNSD
Chi-square test and t test are used to assess statistical significance between groups.
Methods: Lymph node short diameter (LNSD) is measured using CT scan imaging (LNSD > 1cm is considered positive), axillary lymph node status is assessed according to axillary lymph node Doppler ultrasound. ALND will be performed in patients with positive axillary lymph nodes on CT scan; PALND will be performed for those with negative axillary lymph nodes on CT scan but positive on AAUS; SLNB will be performed for those with negative axillary lymph nodes on CT scan and on AAUS.
The prognosis in each patient group is to be evaluated by short-term observational indicators (e.g. lymphedema and/or status of axillary lymphatic return), and long-term indicators (e.g. lymphedema and/or axillary lymph node recurrence). The accuracy of CT scan assessing positive lymph nodes and positive AAUS will be evaluated according to the postoperative histology results.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ALND Group | Experimental | Procedure: ALND GroupALND is performed in patients with positive axillary lymph nodes on CT scan and on AAUS. |
| pALND Group | Experimental | Procedure: ALND GrouppALND is performed in patients with negative axillary lymph nodes on CT scan but positive on AAUS. |
| SLNB Group | Experimental | Procedure: ALND GroupSLNB will be performed for those with negative axillary lymph nodes on CT scan and on AAUS. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Preoperative chest CT and axillary Doppler ultrasound examination in the prone position
- Perform ALND
- Regular post surgery follow-up (short-term and long-term)
Key exclusion criteria (1 listed)
- •History of other benign or malignant tumors causing axillary lymphadenopathy
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 |
|---|---|---|
| ALND GroupAlso: pALND Group, SLNB GroupALND is performed in patients with positive axillary lymph nodes on CT scan and on AAUS. pALND is performed in patients with negative axillary lymph nodes on CT scan but positive on AAUS.SLNB will be performed for those with negative axillary lymph nodes on CT scan and on AAUS. | Procedure or surgery | ALND Group, SLNB Group, pALND Group |
Primary outcome
Agreement rates with postoperative histology
Time frame: Two weeks
The accuracy of CT scan detecting positive axillary lymph node and positive AAUS is assessed by the postoperative histology results
2 secondary outcomes
The incidence of postoperative lymphedema (short-term observational indicator)
Time frame: Two years
Axillary recurrence rate
Time frame: Five years
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 26 Apr 2022.
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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.
Jianyi Li, Dr principal investigator
Cancer Hospital of China Medical University, Liaoning Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ALND Group in people with Breast Cancer, run by Shengjing Hospital at 1 site in China.
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 3 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: looking for participants now, as of the sponsor's last update on 26 Apr 2022. 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 China. 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?
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 Jianyi Li, Dr (8618940257177, sjbreast@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement rates with postoperative histology (time frame: Two weeks). 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 26 Apr 2022.