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

April 25, 2022 updated by: Jianyi Li, Shengjing Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110042
        • Recruiting
        • Liaoning Oncology Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Preoperative chest CT and axillary Doppler ultrasound examination in the prone position
  • Perform ALND
  • Regular post surgery follow-up (short-term and long-term)

Exclusion Criteria:

•History of other benign or malignant tumors causing axillary lymphadenopathy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ALND Group
ALND is performed in patients with positive axillary lymph nodes on CT scan and on AAUS.
Procedure: ALND 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.
Other Names:
  • pALND Group
  • SLNB Group
Experimental: pALND Group
pALND is performed in patients with negative axillary lymph nodes on CT scan but positive on AAUS.
Procedure: ALND 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.
Other Names:
  • pALND Group
  • SLNB Group
Experimental: SLNB Group
SLNB will be performed for those with negative axillary lymph nodes on CT scan and on AAUS.
Procedure: ALND 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.
Other Names:
  • pALND Group
  • SLNB Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Two weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of postoperative lymphedema (short-term observational indicator)
Time Frame: Two years
The purpose of SLNB is to reduce the scope of axillary lymph node dissection, therefore reduce the occurrence of complications.
Two years
Axillary recurrence rate
Time Frame: Five years
Axillary recurrence rate as a long-term observational indicator
Five years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shengjing Hospital

Investigators

  • Principal Investigator: Jianyi Li, Dr, Cancer Hospital of China Medical University, Liaoning Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

August 31, 2027

Study Registration Dates

First Submitted

April 19, 2022

First Submitted That Met QC Criteria

April 25, 2022

First Posted (Actual)

April 26, 2022

Study Record Updates

Last Update Posted (Actual)

April 26, 2022

Last Update Submitted That Met QC Criteria

April 25, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Shengjing-LJY07

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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