The objective of this study is to determine the accuracy of the sentinel lymph node biopsy in multicentric breast cancer prospectively and multi-institutional.
ID
Source
Brief title
Condition
- Other condition
- Breast neoplasms malignant and unspecified (incl nipple)
- Breast therapeutic procedures
Synonym
Health condition
borst diagnostische verrichtingen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- successful identification of sentinel lymph nodes
- mean number of excised sentinel lymph nodes
- number of true positive sentinel lymph nodes
- number of positive non-sentinel lymph nodes at axillary lymph node dissection
o False negative rate= number of false negative SNs/ true positive+ false
negative nodes x 100.
o Sensitivity= true positive/ true positive + false negative x 100
o Negative predictive value= true negative / true negative + false negative x
100
o Accuracy= true positive + true negative/ successful SNBs x 100.
o Likelihood ratio for negative test results=m(1- sensitivity)/ specificity
Secondary outcome
None
Background summary
Multicentric tumors have been considered a contraindication for SLN biopsy due
to the possible higher false negative rate (identification of the **wrong**
SLN). However, recent studies support the theory that the lymphatic pathways
from different sites of the breast converge into one major lymphatic trunk
affering to the same SLN(s).
Study objective
The objective of this study is to determine the accuracy of the sentinel lymph
node biopsy in multicentric breast cancer prospectively and
multi-institutional.
Study design
Patients with preoperative diagnosis of multicentric breast carcinoma,
identified between July the 1st of 2008 and July the 1st of 2010 will undergo
a sentinel lymph node biopsy.
Lymphatic mapping with SLNB will be performed by peri-areolar intradermal
injection of 0,1- 0,2 ml of 25 MBq Tc-99m nanocolloid and Patent Blue dye at 4
sites. All patients will undergo a standard axillary lymph node dissection. The
accuracy of the sentinel lymph node biopsy will be determined.
Study burden and risks
Sentinel lymph node biopsy is a minimally invasive method to determine the
tumorstatus of the axilla.
Radiation exposure:
The radio-isotope 99m Technetium is a relatively short living radio-isotope
with a gammaradiation energy of 140 KeV. The half-life is 6,02 hours, which
means that the amount of radioactivity is half of the original amount after 6
hours. After 18 hours there is only 1/8 of the amount of original activity left
in the patient.
Thus:
- T= 0 intracutaneous injection (20 hours preoperatively) of 25 MBq
99m-Technetium nanocolloid in 4 x 0,1 to 0,2 ml
- T= 17 hours scan (day of operation)
- T= 20 hours operation
When surgery starts three half-lifes have passed and there is less than 12,5
MBq left in the patient.
The radiation exposure for the patient is 2,1 mSV at a given dosis 100 MBq
Tc-99m nanocolloïd. For a surgeon this is 0,5 µS.
Postbus 90153
5200 ME 's Hertogenbosch
NL
Postbus 90153
5200 ME 's Hertogenbosch
NL
Listed location countries
Age
Inclusion criteria
- patients with a preoperative diagnosis of multicentric infiltrating breast carcinoma
- at least 2 positive lesions
- clinically node negative (cN0) breast carcinoma
- also T2-T3 cancers
Exclusion criteria
- ductal or lobular in situ carcinomas
- clinical and/or echographic evidence of positive axilla
- neoadjuvant chemotherapy
- previous ipsilateral breast or axillary surgery
- preoperative radiotherapy
- distant metastases
- pregnant women
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL20280.028.07 |