N/A
ID
Bron
Verkorte titel
Aandoening
breast cancer
lymphatic drainage
borstkanker
lymfedrainage
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
- Technical feasibility of lymphatic mapping
Achtergrond van het onderzoek
Rationale:
Like in primary breast cancer, prognosis in recurrent breast cancer is correlated with regional lymph node status. Therefore, axillary staging may be warranted in patients with recurrent disease and intact axillary nodes, although this has not been described in guidelines yet. The lymphatic drainage pathways in the breast and/or axilla could have been changed due to prior surgery and/or radiotherapy. These aberrant drainage pathways could be detected with lymphatic mapping and sentinel node biopsy (SNB), leading to a more accurate staging.
Objective:
To assess the technical feasibility of lymphoscintigraphy after prior breast surgery (PBS). A second goal is to investigate whether or not previous breast surgery (with or without radiotherapy) significantly changes the lymphatic drainage pathways of the breast.
Study design:
A prospective cohort study.
The intention is to include 50 women above 18 years who underwent PBS in the setting of breastcancer between 01/01/2002 and 31/12/2007. From all included patients a lymphoscintigram will be made which will be compared with pre-operative lymphoscintigram in order to detect changes in lymphatic drainage pathways.
Main study parameters/endpoints:
To assess the technical feasibility of lymphatic mapping in patients who underwent PBS for primary breast cancer. Identification of lymphatic drainage pathways in patients who received PBS.
Doel van het onderzoek
N/A
Onderzoeksopzet
We will evaluate the lymphatic drainage at 1, 3, or 5 years after surgery and/or completement of radiotherapy.
The actual lymphoscintigram will be made at +/- 2 hours after injection of radioactive colloid.
Onderzoeksproduct en/of interventie
Injection of radioactive colloid
Algemeen / deelnemers
Department of surgery <br>
Postbus 1350<br>
5602 ZA Eindhoven
K. Woensdregt
Catharina Ziekenhuis
Michelangelolaan 2
Eindhoven 5623 EJ
The Netherlands
+31 (0)40 2399111
kwoensdregt@hotmail.com
Wetenschappers
Department of surgery <br>
Postbus 1350<br>
5602 ZA Eindhoven
K. Woensdregt
Catharina Ziekenhuis
Michelangelolaan 2
Eindhoven 5623 EJ
The Netherlands
+31 (0)40 2399111
kwoensdregt@hotmail.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Treated for early breast cancer with prior breast surgery, with or without adjuvant systemic therapy between 01/01/2002 and 31/12/2007.
2. Primary tumor localisation in upper-outer, upper-inner, under-outer, under-inner quadrant or peri-areolar
3. Successfully made lymphoscintigram before surgery
4. Prior successful sentinel node procedure with negative sentinel node
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Breast surgery for other reasons than breast cancer
2. Complete axillary lymph node dissection
3. Diagnosed with recurrent breast cancer
4. Former allergic reaction to 99Tc-colloidal albumin
5. Pregnancy
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 | NL1325 |
NTR-old | NTR1385 |
Ander register | NL22080.060.08 : M08-1816 |
ISRCTN | ISRCTN wordt niet meer aangevraagd |