Randomized Controlled Multicenter Surgical Trial to Evaluate the Impact of a Lymphoscintigraphy Prior to Sentinel Node Biopsy in Early Breast Cancer; SenSzi (GBG80)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 1,198
- Locations
- 46
- Primary Endpoint
- Average number of histologically detected sentinel lymph nodes per patient
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Average number of histologically detected sentinel lymph nodes per patient
Time Frame: Histological report expected within an average of 2 weeks after sentinel lymph node biopsy
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.
Secondary Outcomes
- 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(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)