Internal Mammary Sentinel Lymph Node Biopsy in Early Breast Cancer Patients With Clinically Axillary Node -Positive (IMSLNB-CANP)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
In addition to the axillary lymph nodes, the internal mammary lymph nodes (IMLNs) drainage is another important lymphatic channel of the breast. The status of IMLNs also provides important prognostic information for breast cancer patients. The technical evolvements of sentinel lymph node biopsy (SLNB) and lymphoscintigraphy provided a less invasive method for assessing IMLNs than surgical dissection. Recently, many study concerning IMSLNB was performed in the patients with clinically negative axillary nodes. However, previous published studies concerning patients with breast cancer who all underwent a radical mastectomy have shown that IMLN metastases are mostly found concomitantly with axillary metastases. For this reason, IM-SLNB is even more important for clinically axillary node-negative patients. To our knowledge, this is the first attempt of the IM-SLNB in early breast cancer patients with clinically positive axillary nodes.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Procedure: IM-SLNB Radiation: 99mTc-SC Device: Histologic Examination Device: LSG |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Phase III Trail of Internal Mammary Sentinel Lymph Node Biopsy in Early Breast Cancer Patients With Clinically Axillary Node -Positive |
- Number of Participants Whose Lymph Node Staging was Changed with IM-SLNB [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Number of Participants Whose Systemic Treatment was Changed with IM-SLNB [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Visualization Rate of IMSLNs [ Time Frame: 1 year ] [ Designated as safety issue: No ]visualization rate of internal mammary hotspots in lymphoscintigraphy
| Estimated Enrollment: | 4 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: clinically positive axillary nodes
3~18 hours before surgery, under ultrasonographic guidance, 0.5~1.0 mCi 99mTc-SC in sterile saline (total volume 0.2~2.0 mL) is injected intraparenchymally into 2 quadrants of breast. Subsequently, LSG is performed 0.5~1.0 hour before surgery. IM-SLNB is performed during the surgery and the IMSLNs were sent to histologic examination
|
Procedure: IM-SLNB
IM-SLNB is performed according to the pre-operative lymphoscintigraphy
Other Name: Internal Mammary Sentinel Lymph Node Biopsy
Radiation: 99mTc-SC
Two syringes of 0.25~0.5 mCi 99mTc-SC in 0.2~1.0 mL volume were injected intraparenchymally into 2 quadrants of breast, at the 6 and 12 o'clock positions.
Other Name: 99mTc-labeled Sulfur Colloid
Device: Histologic Examination
All IMSLNs were analyzed by histologic examination for future therapy planning.
Other Name: hematoxylin-eosin staining and immunohistochemistry
Device: LSG
lymphoscintigraphy was performed 0.5~1.0 hour before surgery
Other Name: Lymphoscintigraphy
|
Detailed Description:
OBJECTIVES:
- Determine the impact of routinely performed internal mammary sentinel lymph node biopsy on the systemic and locoregional treatments plan.
- Evaluate the metastasis rate of internal mammary sentinel lymph nodes in patients with clinically axillary node-positive.
- Draw the learning curve of internal mammary sentinel lymph node biopsy.
OUTLINE:
3~18 hours before surgery, under ultrasonographic guidance, 0.5~1.0 mCi 99mTc-labeled sulfur colloid in sterile saline (total volume 0.2~2.0 mL) is injected intraparenchymally into 2 quadrants of breast. Subsequently, lymphoscintigraphy is performed 0.5~1.0 hour before surgery. internal mammary sentinel lymph node biopsy is performed during the surgery and the internal mammary sentinel lymph nodes were sent to histologic examination.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- primary breast cancer
- clinically axilla-positive
Exclusion Criteria:
- enlarged internal mammary nodes by imaging
Contacts and Locations| Contact: Yong-sheng Wang, MD | +8653167626211 | wangysh2008@yahoo.com.cn |
| Contact: Peng-fei Qiu, MD | +8615168872002 | qiupengfei2002@yahoo.cn |
| China, Shandong | |
| Shandong Cancer Hospital | Recruiting |
| Jinan, Shandong, China, 250117 | |
| Contact: Yong-sheng Wang, MD +8653167626211 wangysh2008@yahoo.com.cn | |
| Contact: Peng-fei Qiu, MD +8615168872002 qiupengfei2002@yahoo.cn | |
| Principal Investigator: Yong-sheng Wang, MD | |
| Principal Investigator: Peng-fei Qiu, MD | |
| Principal Investigator: Yan-bing Liu, MD | |
| Study Chair: | Yong-sheng Wang, MD | Shandong Cancer Hospital |
| Principal Investigator: | Peng-fei Qiu, MD | Shandong Cancer Hospital |
| Principal Investigator: | Yan-bing Liu, MD | Shandong Cancer Hospital |
More Information
No publications provided
| Responsible Party: | Yongsheng Wang, Director, Head of Breast Cancer Center, Principal Investigator, Clinical Professor, Shandong Cancer Hospital and Institute |
| ClinicalTrials.gov Identifier: | NCT01668914 History of Changes |
| Other Study ID Numbers: | IMSN002 |
| Study First Received: | August 16, 2012 |
| Last Updated: | October 21, 2012 |
| Health Authority: | China: Ministry of Health |
Keywords provided by Shandong Cancer Hospital and Institute:
|
Breast Cancer Clinically Axillary Node -Positive Sentinel Lymph Node Biopsy Internal Mammary |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 19, 2013