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

Kliniken Essen-Mitte

Status: Completed

Conditions: Early-Stage Breast Carcinoma

Treatments: Procedure: without preoperative access to lymphoscintigraphy findings

Study type: Interventional

Funder types: Other

Identifiers

NCT02481128

SenSzi (GBG80)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,198 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,198 participants in 2 patient groups

A (access to lymphoscintigraphy)

No Intervention group

Description:

Axillary sentinel lymph node biopsy with preoperative access to lymphoscintigraphy findings

B (no access to lymphoscintigraphy)

Experimental group

Description:

Axillary sentinel lymph node biopsy without preoperative access to lymphoscintigraphy findings

Treatment:

Procedure: without preoperative access to lymphoscintigraphy findings