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

NCT05346510 | Recruiting DMC

• 1 other identifier: Shengjing-LJY07
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Breast Cancer

Keywords

Breast cancer; axillary lymph node; prone positioning computed tomography; ultrasound

Outcome Measures

Primary Outcomes (1)

• 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

  Two weeks

Secondary Outcomes (2)

• The incidence of postoperative lymphedema (short-term observational indicator)

  Two years

• Axillary recurrence rate

  Five years

Study Arms (3)

ALND Group

EXPERIMENTAL

ALND is performed in patients with positive axillary lymph nodes on CT scan and on AAUS.

Procedure: ALND Group

pALND Group

EXPERIMENTAL

pALND is performed in patients with negative axillary lymph nodes on CT scan but positive on AAUS.

Procedure: ALND Group

SLNB Group

EXPERIMENTAL

SLNB will be performed for those with negative axillary lymph nodes on CT scan and on AAUS.

Procedure: ALND Group

Interventions

ALND Group PROCEDURE

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.

Also known as: pALND Group, SLNB Group

ALND Group; SLNB Group; pALND Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• History of other benign or malignant tumors causing axillary lymphadenopathy

Sponsors & Collaborators

• Shengjing Hospital: lead

Study Sites (1)

Liaoning Oncology Hospital

Shenyang, Liaoning, 110042, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jianyi Li, Dr

  Cancer Hospital of China Medical University, Liaoning Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianyi Li, Dr

CONTACT

8618940257177; sjbreast@yeah.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: April 26, 2022
• Study Start: March 1, 2022
• Primary Completion: September 1, 2022
• Study Completion (Estimated): August 31, 2027
• Last Updated: April 26, 2022

Record last verified: 2022-04

Locations

CN (1)