|- candidate number||20921|
|- NTR Number||NTR4903|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||14-nov-2014|
|- Secondary IDs||METC Twene P14-32 NL49285.044.14|
|- Public Title||Radiation-free, magnetic, sentinel lymph node detection and evaluation |
|- Scientific Title||Low dose SPIO injection for a complete magnetic, radiation-free, procedure for sentinel lymph node detection and metastases evaluation.|
|- hypothesis||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. |
|- Healt Condition(s) or Problem(s) studied||Breast cancer, Sentinel lymph node localization, Sentinel lymph node|
|- Inclusion criteria||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;|
|- Exclusion criteria||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.
|- mec approval received||yes|
|- multicenter trial||no|
|- planned startdate ||1-jan-2015|
|- planned closingdate||1-jul-2016|
|- Target number of participants||70|
|- Interventions||A low dose peritumoral injection of Sienna+ (2x 0.5 mL), with a total dose of approximately 1.1 mg iron.|
|- Primary outcome||1. The proportion of sentinel nodes correctly detected with the magnetic method compared to the combined technique (visually and/or using the gammaprobe).|
2. The proportion of patients in which the sentinel lymph nodes could successfully be detected (detection rate) using the magnetometer.
3. The number and percentage of sentinel lymph nodes correctly diagnosed to be metastatic using ex vivo MRI „³ sensitivity;
4. The number and percentage of sentinel lymph nodes correctly diagnosed to be non-metastatic using ex vivo MRI specificity.
|- Secondary outcome||5. The iron content in the dissected sentinel lymph nodes (average, minimum and maximum) in relation to the image quality;|
6. The image parameters indicative for the presence of sentinel lymph node metastases;
7. The requirements in detection depth and minimally detectable mg iron per node for future magnetometers;
8. The usability of a dose of 1.1 mg iron in 1 ml injected volume for the proposed study.
|- Timepoints||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.|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||Dr. M. Heijblom|
|- CONTACT for SCIENTIFIC QUERIES||Dr. M. Heijblom|
|- Sponsor/Initiator ||University of Twente|
(Source(s) of Monetary or Material Support)
|Stichting Technologische Wetenschappen (STW), Medisch Spectrum Twente|
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||14-nov-2014 - 22-dec-2014|