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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

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
ALND Group
Sponsored by
Shengjing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring Breast cancer, axillary lymph node, prone positioning computed tomography, ultrasound

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Liaoning Oncology HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

ALND Group

pALND Group

SLNB Group

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Axillary recurrence rate
Axillary recurrence rate as a long-term observational indicator

Full Information

First Posted
April 19, 2022
Last Updated
April 25, 2022
Sponsor
Shengjing Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05346510
Brief Title
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
Official Title
Evaluation of Axillary Lymph Nodes Using Prone Positioning Computed Tomography Scan and Ultrasound in Patients With Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
August 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shengjing Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast cancer, axillary lymph node, prone positioning computed tomography, ultrasound

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ALND Group
Arm Type
Experimental
Arm Description
ALND is performed in patients with positive axillary lymph nodes on CT scan and on AAUS.
Arm Title
pALND Group
Arm Type
Experimental
Arm Description
pALND is performed in patients with negative axillary lymph nodes on CT scan but positive on AAUS.
Arm Title
SLNB Group
Arm Type
Experimental
Arm Description
SLNB will be performed for those with negative axillary lymph nodes on CT scan and on AAUS.
Intervention Type
Procedure
Intervention Name(s)
ALND Group
Other Intervention Name(s)
pALND Group, SLNB Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Agreement rates with postoperative histology
Description
The accuracy of CT scan detecting positive axillary lymph node and positive AAUS is assessed by the postoperative histology results
Time Frame
Two weeks
Secondary Outcome Measure Information:
Title
The incidence of postoperative lymphedema (short-term observational indicator)
Description
The purpose of SLNB is to reduce the scope of axillary lymph node dissection, therefore reduce the occurrence of complications.
Time Frame
Two years
Title
Axillary recurrence rate
Description
Axillary recurrence rate as a long-term observational indicator
Time Frame
Five years

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianyi Li, Dr
Phone
8618940257177
Email
sjbreast@yeah.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianyi Li, Dr
Organizational Affiliation
Cancer Hospital of China Medical University, Liaoning Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Liaoning Oncology Hospital
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110042
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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