|- candidate number||3644|
|- NTR Number||NTR1385|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||17-jul-2008|
|- Secondary IDs||M08-1816 NL22080.060.08|
|- Public Title||Lymphatic drainage after prior breast surgery|
|- Scientific Title||Lymphatic mapping after prior sentinel node negative breast surgery|
|- Healt Condition(s) or Problem(s) studied||Mamma carcinoma, Breast cancer, Lymphatic drainage|
|- Inclusion criteria||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
|- Exclusion criteria||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
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-aug-2008|
|- planned closingdate||1-aug-2009|
|- Target number of participants||50|
|- Interventions||Injection of radioactive colloid|
|- Primary outcome||- Technical feasibility of lymphatic mapping|
|- Secondary outcome||To determine (changes in) lymphatic drainage pathways in patients with (gossly) intact axillary lymph nodes after prior breast surgery|
|- Timepoints||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.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| K. Woensdregt|
|- CONTACT for SCIENTIFIC QUERIES|| K. Woensdregt|
|- Sponsor/Initiator ||Catharina Hospital Eindhoven, Department of Surgery|
(Source(s) of Monetary or Material Support)
|Catharina Hospital Eindhoven, Department of Surgery|
|- Brief summary||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.
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.
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.
|- Main changes (audit trail)|
|- RECORD||17-jul-2008 - 25-jul-2008|