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Application of Preoperative Axillary Lymph Node Marking With Nano-Carbon in Breast Cancer Patients Before Neoadjuvant Chemotherapy

Primary Purpose

Breast Cancer, Neoadjuvant Therapy, Sentinel Lymph Node Biopsy

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
carbon dye
Sponsored by
Fujian Medical University Union Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

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

Inclusion Criteria:

  1. Female; 2. Aged >=18 years; 3. With invasive breast cancer; 4. Patients to be treated with neoadjuvant chemotherapy; 5. Patients scheduled to undergo routine fine needle aspiration (FNA) or core biopsy of abnormal axillary lymph node; 6. Patients with operable breast cancer; 7. Heart, lung, liver and kidney function well, suitable for patients undergoing surgery; 8. Informed consent patients.

Exclusion Criteria:

  • 1. Patients who do not plan or are unable to operate; 2. Patients with distant metastasis were excluded; 3. Patients without invasive cancer components in DCIS alone; 4. Patients who are unable to cooperate with the doctor's recommended surgical treatment (breast conserving surgery or radical surgery) due to personal or family factors; 5. Patients with serious cardiopulmonary diseases, uncontrolled infectious diseases and other non tumor related diseases who can not tolerate comprehensive treatment such as surgery and chemotherapy; 6. Patients with mental illness or other reasons unable to sign informed consent; 7. Patients with poor medical compliance who cannot complete the trial treatment process and follow-up according to the standard according to the researcher's opinion.

Sites / Locations

  • Study OfficialsRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Experimental: Tattooing of biopsied node

Arm Description

Prior to NST, suspicious axillary lymph nodes were biopsied by core needle or fne needle aspiration. The largest and/or biopsy-confrmed metastastic node was then injected with highly purifed carbon suspension either at the time of biopsy or at a separate session.

Outcomes

Primary Outcome Measures

Identification rate of tattooed node
Proportion of patients in whom tattooed node/s were identified.

Secondary Outcome Measures

Concordance of tattooed node and sentinel node
Concordance rate: defined as the percent of patients in whomthe tattooed nodeis the sentinel node.
Migration of black dye into other nodes
The number of black nodes at the time of sentinel node biopsy or axillary lymph node dissection.

Full Information

First Posted
August 22, 2022
Last Updated
August 22, 2022
Sponsor
Fujian Medical University Union Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05512468
Brief Title
Application of Preoperative Axillary Lymph Node Marking With Nano-Carbon in Breast Cancer Patients Before Neoadjuvant Chemotherapy
Official Title
Application of Preoperative Axillary Lymph Node Marking With Nano-Carbon in Breast Cancer Patients Before Neoadjuvant Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fujian Medical University Union Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The primary aim of this prospective, multicentre study is to determine whether the involved node can be marked using black carbon dye and successfully identified at the time of surgery. The secondary aims are to determine the concordance between the tattooed node and sentinel node, migration of black dye into other nodes, and false-negative rate of tattooed node (in patients undergoing ALND after NACT).
Detailed Description
Pretreatment evaluation of axillary lymph nodes and marking of biopsied nodes in patients with newly diagnosed breast cancer is becoming routine practice. Tagging of biopsied axillary lymph nodes with metal markers, similar to what is done for suspicious breast lesions, is being adopted in clinical practice. The need to mark a positive axillary lymph node becomes especially relevant in cases where neoadjuvant chemotherapy (NACT) is anticipated so that these nodes may be identified at the time of surgery. Measures that improve both the accuracy of nodal evaluation after NACT and the ability to assess treatment response are desirable in order to tailor therapies for breast cancer treatment. The investigators sought to test tattooing of biopsied axillary lymph nodes with a sterile black carbon suspension.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Neoadjuvant Therapy, Sentinel Lymph Node Biopsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Tattooing of biopsied node
Arm Type
Other
Arm Description
Prior to NST, suspicious axillary lymph nodes were biopsied by core needle or fne needle aspiration. The largest and/or biopsy-confrmed metastastic node was then injected with highly purifed carbon suspension either at the time of biopsy or at a separate session.
Intervention Type
Drug
Intervention Name(s)
carbon dye
Intervention Description
Tattooing (marking) of biopsied node with carbon dye at the time or at a separate session of fine needle aspiration or core biopsy or separate visit under ultrasound guidance. The dye will be injected in the cortex of the node and the perinodal tissue under ultrasound guidance. Patients will undergo standard (routine) armpit surgery and may receive neoadjuvant chemotherapy as planned by the clinical team. This could be removal of a few lymph glands (sentinel node biopsy) or removal of all the lymph glands (axillary lymph node dissection) in the armpit. The surgeon will try to identify and remove the tattooed lymph gland at the time of planned armpit surgery.
Primary Outcome Measure Information:
Title
Identification rate of tattooed node
Description
Proportion of patients in whom tattooed node/s were identified.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Concordance of tattooed node and sentinel node
Description
Concordance rate: defined as the percent of patients in whomthe tattooed nodeis the sentinel node.
Time Frame
12 months
Title
Migration of black dye into other nodes
Description
The number of black nodes at the time of sentinel node biopsy or axillary lymph node dissection.
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female; 2. Aged >=18 years; 3. With invasive breast cancer; 4. Patients to be treated with neoadjuvant chemotherapy; 5. Patients scheduled to undergo routine fine needle aspiration (FNA) or core biopsy of abnormal axillary lymph node; 6. Patients with operable breast cancer; 7. Heart, lung, liver and kidney function well, suitable for patients undergoing surgery; 8. Informed consent patients. Exclusion Criteria: 1. Patients who do not plan or are unable to operate; 2. Patients with distant metastasis were excluded; 3. Patients without invasive cancer components in DCIS alone; 4. Patients who are unable to cooperate with the doctor's recommended surgical treatment (breast conserving surgery or radical surgery) due to personal or family factors; 5. Patients with serious cardiopulmonary diseases, uncontrolled infectious diseases and other non tumor related diseases who can not tolerate comprehensive treatment such as surgery and chemotherapy; 6. Patients with mental illness or other reasons unable to sign informed consent; 7. Patients with poor medical compliance who cannot complete the trial treatment process and follow-up according to the standard according to the researcher's opinion.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chuan Wang
Phone
13365910252
Email
chuanwang1968@outlook.com
First Name & Middle Initial & Last Name or Official Title & Degree
Minyan Chen
Phone
15980278832
Email
15980278832@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
China Fujian
Organizational Affiliation
Fujian Medical University Union Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Study Officials
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chuan Wang
Phone
13365910252
Email
chuanwang1968@outlook.com
First Name & Middle Initial & Last Name & Degree
Minyan Chen
Phone
15980278832
Email
15980278832@163.com

12. IPD Sharing Statement

Learn more about this trial

Application of Preoperative Axillary Lymph Node Marking With Nano-Carbon in Breast Cancer Patients Before Neoadjuvant Chemotherapy

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