Surgical Trial to Evaluate the Impact of a Lymphoscintigraphy Prior to Sentinel Node Biopsy in Early Breast Cancer

Study Overview
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Brief Summary
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Sentinel node biopsy is a well established tool for axillary staging in early breast cancer. So far the impact of a preoperative lymph node scintigraphy is unclear. This study aims to clarify whether a preoperative lymphoscintigraphy is of additional benefit in a prospective randomized multicenter study design.

Detailed Description
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Sentinel node biopsy is a well established tool for axillary staging in early breast cancer. So far the impact of a preoperative lymph node scintigraphy is unclear. Several studies indicate sentinel node biopsy to be a reliable method irrespective of prior lymph node scintigraphy, but data from prospective randomized trials are not available. Although a preoperative lymph node scintigraphy is not explicitly demanded in current S3 guidelines in Germany its performance is a common practice. If a preoperative lymphoscintigraphy could be safely omitted, possible benefits are a facilitation of the preoperative workflow as well as cost reduction for health care systems. This study aims to clarify whether a preoperative lymphoscintigraphy is of additional benefit in a prospective randomized study design. In the two study arms sentinel node biopsy is performed either with or without knowledge of the preoperative lymphoscintigraphy findings. Primary end point is the average number of histologically detected sentinel lymph nodes per patient in both treatment arms.

Official Title
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Randomized Controlled Multicenter Surgical Trial to Evaluate the Impact of a Lymphoscintigraphy Prior to Sentinel Node Biopsy in Early Breast Cancer; SenSzi (GBG80)

Conditions
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Early-Stage Breast Carcinoma

Intervention / Treatment
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* Procedure: without preoperative access to lymphoscintigraphy findings


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: invasive mamma carcinoma as verified by core cut biopsy extensive ductal carcinoma in situ as verified by core cut biopsy (at least 5 cm or at least 2,5 cm and G3 grading) clinical stage tumor T1-T3 no signs of axillary lymph node metastasis on clinical examination including ultrasound examination no signs of distant metastatic disease male/ female patient in the age not less than 18 years Karnofsky performance status at least 70% or Eastern Cooperative Oncology Group (ECOG) score not higher than 1 written patient informed consent Exclusion Criteria: suspect axillary lymph nodes on clinical/ultrasound examination positive fine-needle biopsy of axillary lymph nodes sentinel lymph node biopsy to be performed after neoadjuvant chemotherapy recurrence of a mamma carcinoma prior extensive surgery of breast or axilla inflammatory or extramammary breast cancer pregnancy contraindication to the radionuclide inability to understand the studies purpose inability to receive surgery no written patient informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: A (access to lymphoscintigraphy)<br>Axillary sentinel lymph node biopsy with preoperative access to lymphoscintigraphy findings | |
| Experimental: B (no access to lymphoscintigraphy)<br>Axillary sentinel lymph node biopsy without preoperative access to lymphoscintigraphy findings | Procedure: without preoperative access to lymphoscintigraphy findings<br>* axillary sentinel lymph node biopsy without access to lymphoscintigraphy findings<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average number of histologically detected sentinel lymph nodes per patient | Number of resected sentinel lymph nodes is inversely correlated with false negative rate of sentinel lymph node biopsy. Average number of histologically detected sentinel lymph nodes per patient is assessed through pathologic report and serves as surrogate marker for false negative rate of sentinel node biopsy. | Histological report expected within an average of 2 weeks after sentinel lymph node biopsy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients with proven metastasis in sentinel lymph nodes |  | Histological report expected within an average of 2 weeks after sentinel lymph node biopsy | 
| Rate of completion axillary dissection with proven metastasis in sentinel lymph nodes | A completion axillary dissection can be performed in case of proven metastasis in sentinel lymph nodes. A completion axillary dissection ca be performed either right away during sentinel lymph node biopsy or after completion of neoadjuvant chemotherapy. Hence assessment will be performed within 6 months after initial sentinel lymph node biopsy in order to include all patients planned for neoadjuvant chemotherapy. | histological report on subsequent completion axillary dissection within 6 months after initial sentinel lymph node biopsy | 
| Detection rates of sentinel nodes lymph nodes with preoperative lymphoscintigraphy vs. intraoperative gamma probe and histological detection rates of sentinel lymph nodes with vs. without preoperative access to lymphoscintigraphy |  | Histological report expected within an average of 2 weeks after sentinel lymph node biopsy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lymphoscintigraphy, sentinel lymph node biopsy