The sentinel lymph nodes (SLN) are the first lymph nodes to drain the tumor site and therefore the first lymph nodes to bare metastases. Hence the importance to investigate these lymph nodes to define the best treatment strategy. Currently in a.o.…
ID
Bron
Verkorte titel
Aandoening
Breast cancer, borstkanker
Results are also applicable to melanoma, prostate cancer.
Resultaten zijn ook toepasbaar op melanoom en prostaatkanker.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. The proportion of sentinel nodes correctly detected with the magnetic method compared to the combined technique (visually and/or using the gammaprobe).<br>
2. The proportion of patients in which the sentinel lymph nodes could successfully be detected (detection rate) using the magnetometer.<br>
3. The number and percentage of sentinel lymph nodes correctly diagnosed to be metastatic using ex vivo MRI „³ sensitivity;<br>
4. The number and percentage of sentinel lymph nodes correctly diagnosed to be non-metastatic using ex vivo MRI specificity.
Doel van het onderzoek
The sentinel lymph nodes (SLN) are the first lymph nodes to drain the tumor site and therefore the first lymph nodes to bare metastases. Hence the importance to investigate these lymph nodes to define the best treatment strategy. Currently in a.o. breast cancer and melanoma patients, the sentinel lymph nodes are intraoperatively detected, both visually and by using a gamma probe, following the subsequent injections of radioactive tracer (Tc 99-m) and blue dye (Patent Blue). Histopathological investigation of the resected sentinel lymph nodes should then confirm the presence or absence of metastases. The conventional methods for sentinel lymph node biopsy suffer from disadvantages, such as the use of radioactive materials and the fact that node-positive patients require multiple surgical procedures. At the NeuroImaging (NIM) group of the University of Twente, we investigate a magnetic, radiation-free, procedure for sentinel lymph node detection and evaluation. Several aspects of this procedure have been investigated in separate studies. Though results were promising, showing a detection rate of the sentinel node non-inferior to the existing technique and proving the feasibility to visualize the sentinel node in preoperative MRI, the doses and volume of the injected magnetic tracer (SuperParamagnetic Iron Oxide particles, SPIO), were relatively high. The high dose of iron potentially leads to difficulties in evaluating lymph nodes with small metastases and to substantial skin staining. Additionally, the high volume of injected tracer might in some cases lead to a non-physiological uptake of iron in the lymph vessels, reducing the reliability for detecting (solely) sentinel lymph nodes. In this study, the aim is to investigate the feasibility of using low dose SPIO (50x lower than the previously safely used dose) for both evaluation and detection of the sentinel lymph node in breast cancer patients.
Onderzoeksopzet
The study outcomes will be evaluated after every ten successful measurements, after every 5 MRI investigations on specimen containing macrometastases, after every 5 MRI investigations on specimen not containing metastases and at the end of the study.
Onderzoeksproduct en/of interventie
A low dose peritumoral injection of Sienna+ (2x 0.5 mL), with a total dose of approximately 1.1 mg iron.
Publiek
University of Twente<br>
P.O. Box 217
M. Heijblom
Enschede 7500 AE
The Netherlands
+31 (0)53 4893877
m.heijblom@utwente.nl
Wetenschappelijk
University of Twente<br>
P.O. Box 217
M. Heijblom
Enschede 7500 AE
The Netherlands
+31 (0)53 4893877
m.heijblom@utwente.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Adult, clinically (palpation and ultrasound) node negative, patients that are diagnosed with invasive breast cancer or high grade ductal carcinoma in situ and that are scheduled for a two-day SLNB procedure and that gave informed consent for participation to the study;
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1.Patients incapable of giving informed consent for participation to the study;
2.Intolerance / hypersensitivity to iron or dextran compounds;
3.Patients that have received neoadjuvant chemotherapy in the period of 5 years prior to this study.
4.Pregnant or lactating patients
5.Patients having a pacemaker implanted.
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
NTR-new | NL4698 |
NTR-old | NTR4903 |
Ander register | NL49285.044.14 : METC Twene P14-32 |