Clinical trial · Interventional
Surgical Trial to Evaluate the Impact of a Lymphoscintigraphy Prior to Sentinel Node Biopsy in Early Breast Cancer
Randomized Controlled Multicenter Surgical Trial to Evaluate the Impact of a Lymphoscintigraphy Prior to Sentinel Node Biopsy in Early Breast Cancer; SenSzi (GBG80)
NCT02481128CI-TRIAL-00045889completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early-Stage Breast Carcinoma | Early Stage Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| without preoperative access to lymphoscintigraphy findings | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- A (access to lymphoscintigraphy)
- description
- Axillary sentinel lymph node biopsy with preoperative access to lymphoscintigraphy findings
- type
- EXPERIMENTAL
- label
- B (no access to lymphoscintigraphy)
- description
- Axillary sentinel lymph node biopsy without preoperative access to lymphoscintigraphy findings
- interventionNames
- Procedure: without preoperative access to lymphoscintigraphy findings
Primary outcomes (1)
- measure
- Average number of histologically detected sentinel lymph nodes per patient
- timeFrame
- Histological report expected within an average of 2 weeks after sentinel lymph node biopsy
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- RESULTKuemmel S, Holtschmidt J, Gerber B, Von der Assen A, Heil J, Thill M, Krug D, Schem C, Denkert C, Lubitz J, Blohmer JU, Reinisch M, Hotzeldt M, Seither F, Nekljudova V, Schwidde I, Uhrhan K, Von Minckwitz G, Rezai M, Mulowski J, Loibl S, Kuehn T. Prospective, Multicenter, Randomized Phase III Trial Evaluating the Impact of Lymphoscintigraphy as Part of Sentinel Node Biopsy in Early Breast Cancer: SenSzi (GBG80) Trial. J Clin Oncol. 2019 Jun 10;37(17):1490-1498. doi: 10.1200/JCO.18.02092. Epub 2019 May 1. PMID 31042410
- RESULTHoltschmidt J, Kuemmel S, Krug D, Breit E, Kuehn T, Reinisch M. Reply to E. Hindie and A.K. Goel et al. J Clin Oncol. 2019 Oct 10;37(29):2705-2707. doi: 10.1200/JCO.19.01860. Epub 2019 Aug 29. No abstract available. PMID 31465263