Due to surgery and radiotherapy lymph drainage pathways in recurrent breast cancer could be altered. These aberrant drainage pathways could be detected with lymphatic mapping and sentinel node biopsy leading to a more thorough staging and possible…
ID
Bron
Verkorte titel
Aandoening
Recurrent breast cancer
Sentinel node biopsie
Recidief mammacarcinoom
Schildwachtklierprocedure
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
- Registration of technical feasibility of lymphatic mapping and sentinel node biopsy in patients with locally recurrent breast cancer.<br>
- Registration of success rate of lymphatic mapping and SNB in patients with locally recurrent breast cancer.<br>
- Registration of validity of lymphatic mapping and sentinel node biopsy in patients with locally recurrent breast cancer.
Achtergrond van het onderzoek
Rationale:
Like in primary breast cancer, prognosis in recurrent breast cancer is correlated with regional lymph node status. Therefore, it seems sensible to perform lymphatic staging in case of an intact axillary lymph node basin, although this has not been described in guidelines yet. Due to surgery and radiotherapy lymph drainage pathways could be altered. These aberrant drainage pathways could be detected with lymphatic mapping and sentinel node biopsy leading to a more thorough staging and possible change in treatment strategy.
Objective:
To propose a regional staging protocol, lymphatic mapping and sentinel node biopsy, for patients with locally recurrent breast cancer in the absence of guidelines for regional staging procedures and to registrate data derived from this study.
Study design:
A prospective, multicenter, national registration study.
Study population:
At least 150 women above 18 years old with locally recurrent breast cancer after earlier BCT or modified radical mastectomy.
Main study parameters/endpoints:
Registration of technical feasibility and validity of lymphatic mapping and sentinel node biopsy in patients with locally recurrent breast cancer as well as registration of lymphatic drainage pathways and sentinel lymph node status. Furthermore, the influence of this staging procedure on therapeutic decisions will be evaluated.
Doel van het onderzoek
Due to surgery and radiotherapy lymph drainage pathways in recurrent breast cancer could be altered. These aberrant drainage pathways could be detected with lymphatic mapping and sentinel node biopsy leading to a more thorough staging and possible change in treatment strategy.
Onderzoeksopzet
- Pre-operative inclusion
- Operation
- Post-operative registration: first post-operative consult
Onderzoeksproduct en/of interventie
Lymfatic Mapping and sentinel lymph node biopsie.
Publiek
Afdeling chirurgie
A. Maaskant-Braat
Michelangelolaan 2
5623 EJ Eindhoven
Eindhoven
The Netherlands
+31 (0)40 2399111 / 7174
SNARBgroup@gmail.com
Wetenschappelijk
Afdeling chirurgie
A. Maaskant-Braat
Michelangelolaan 2
5623 EJ Eindhoven
Eindhoven
The Netherlands
+31 (0)40 2399111 / 7174
SNARBgroup@gmail.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Women above 18 years old with locally recurrent breast cancer after earlier BCT or modified radical mastectomy.
2. Operable cytological /histological confirmed locally recurrent breast cancer.
3. Having obtained an informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Proven ipsi- or contralateral regional lymph node metastases (ultrasound and FNA).
2. Known to be allergic to “99mTc-colloidal albumin” or blue dye injection fluids.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL1390 |
NTR-old | NTR1450 |
Ander register | NL 19199.060.07 : M07-1792 |
ISRCTN | ISRCTN wordt niet meer aangevraagd |