Internal Mammary Sentinel Lymph Node Biopsy With Modified Injection Technique
A Prospective Multicenter Clinical Trial of Internal Mammary Sentinel Lymph Node Biopsy With Modified Injection Technique for Early Breast Cancer
1 other identifier
interventional
350
1 country
1
Brief Summary
Internal Mammary Lymph Node (IMLN) and Axillary Lymph Node (ALN) are regarded as "the first station" of lymphatic drainage in breast cancer, serving as an important reference for lymph staging and decision-making. Although the concept of Internal Mammary Sentinel Lymph Node Biopsy (IM-SLNB) has been included in the AJCC guidelines since the 6th edition, technical bottlenecks and clinical benefits still remained to be the main reasons limiting its clinical application: Technical bottlenecks: In previous clinical practice, the internal mammary visualization rate was very low (13% on average, 0% -37%) under the guidance of the traditional radionuclide injection technique, which became a technology bottleneck restricting the widespread of IM-SLNB. After continuous exploration, our center invented the "modified injection technique" of injecting the nuclide tracer into the mammary gland layer at 6 and 12 o'clock around the areolar under the guidance of ultrasound, as well as increasing the injection volume to increase the local tension. A high internal mammary imaging rate of 71% was obtained, which laid a foundation for the further study and clinical application of IM-SLNB. Clinical benefits: The IM-SLNB is a method to assess IMLN metastatic status in a minimally invasive way, which may improve the system of regional staging and guide precise IMLN treatment. However, based on the current IM-SLNB indication, the internal mammary metastasis rate was only 8%-15%, and it only had little influence on treatment strategy, which led to the controversy of its clinical application. Previous studies of extended radical mastectomy showed that in ALN positive patients the IMLN metastasis rate was 28-52%, while in ALN negative patients the metastasis rate was only 5-17%. Therefore, the continuation of the previous A-SLNB indication (clinical ALN negative) to IM-SLNB is apparently not in line with the current clinical practice, but further evaluation of internal mammary metastasis status in clinical ALN positive patients may receive greater benefit. This prospective multicenter study attempted to perform IM-SLNB with our modified injection technique both in clinical ALN negative and positive patients for the first time. Through analyzing metastasis rate of IMLN as well as the influences it had on decision making, we hoped to develop more accurate indication for IM-SLNB and guide the individualized precise treatment of IMLN.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Jul 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 18, 2018
CompletedFirst Posted
Study publicly available on registry
May 30, 2018
CompletedStudy Start
First participant enrolled
July 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedMay 30, 2018
May 1, 2018
2 years
May 18, 2018
May 18, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Visualization Rate
The internal mammary sentinel lymph node visualization rate with our modified injection techniques
2 year
Secondary Outcomes (4)
Success rate of IM-SLNB
2 year
Frequency and Severity of Complications with IM-SLNB
2 year
Metastasis Rate of IMSLN
2 year
Clinical Benefits
2 year
Study Arms (1)
IM-SLNB with MIT
EXPERIMENTALThe radiotracer was injected with our modified injection technique (MIT) (periareolar intraparenchymal, high volume and ultrasonographic guidance). Internal mammary sentinel lymph node biopsy (IM-SLNB) was performed for patients with internal mammary visualized.
Interventions
Eligibility Criteria
You may qualify if:
- Patients with preoperative pathology confirmed invasive breast cancer;
- Clinical T1-3 N0-3 M0 (with positive fine-needle aspiration result in their clinical or ultrasonic suspicious axillary lymph node ; no clinical or radiologic evidence of distant metastases);
- Be able and willing to sign informed consent forms.
You may not qualify if:
- Patients with enlarged internal mammary nodes by imaging;
- Patients who have received neoadjuvant therapy (including neoadjuvant chemotherapy and / or endocrine therapy);
- Patients with a previous history of breast cancer (recurrence of breast cancer and contralateral breast cancer);
- Patients with a history of other malignancies;
- Patients who have had previous surgery in axillary or internal mammary;
- Patients in pregnancy and lactation;
- Patients participant in other clinical trials that will have an impact on the results of this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shandong Cancer Hospital and Institutelead
- The Affiliated Hospital of Qingdao Universitycollaborator
- Henan Cancer Hospitalcollaborator
Study Sites (1)
Shandong Cancer Hospital and Institute
Jinan, Shandong, 250117, China
Related Publications (1)
Qiu PF, Liu JJ, Liu YB, Yang GR, Sun X, Wang YS. A modified technology could significantly improve the visualization rate of the internal mammary sentinel lymph nodes in breast cancer patients. Breast Cancer Res Treat. 2012 Nov;136(1):319-21. doi: 10.1007/s10549-012-2203-5. Epub 2012 Sep 6. No abstract available.
PMID: 22956005BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yong-Sheng Yong-Sheng, MD
Shandong Cancer Hospital and Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Head of Breast Cancer Center, Principal Investigator, Clinical Professor
Study Record Dates
First Submitted
May 18, 2018
First Posted
May 30, 2018
Study Start
July 1, 2018
Primary Completion
June 30, 2020
Study Completion
December 31, 2020
Last Updated
May 30, 2018
Record last verified: 2018-05