Breast Neoplasms Clinical Trial
— Sentimag02Official title:
Sienna+® Injection Time Study: A Prospective Multicentre, Controlled Clinical Trial to Evaluate the Performance of Superparamagnetic Iron Oxide vs. Standard Technique as Tracer in Sentinel Node Biopsy
Patients with breast cancer normally undergo a labelling with radioactive tracer typically 1 day before surgery, which enables the surgeon to localize the sentinel lymph node during surgery. This pilot study uses the magnetic Sentimag technique to mark the lymph nodes either 1 or 4-6 days before surgery to investigate the concordance with the standard technique.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | June 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Subject has a diagnosis of primary breast cancer - Subject has been scheduled for surgery with a sentinel lymph node biopsy procedure - Subject is =18 years old at time of consent - Subject has an ECOG performance status of Grade 0-2 - Subject has a clinical negative node status - Subject is available for the follow-up Exclusion Criteria: - Subject is pregnant or lactating - Subject has a radiological evidence of metastatic cancer - Subject has had previous axilla surgery or reduction mammoplasty - Subject has impaired lymphatic function - Subject has had a preoperative radiation therapy - Subject has iron overload disease or iron/dextran intolerance - Subject has a pacemaker - Subject is under guardianship |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Switzerland | Kantonsspital Baden | Baden | |
Switzerland | Inselspital Bern, Universitätsklinik für Frauen. | Berne |
Lead Sponsor | Collaborator |
---|---|
Kantonsspital Baden | University Hospital Inselspital, Berne |
Switzerland,
Douek M, Klaase J, Monypenny I, Kothari A, Zechmeister K, Brown D, Wyld L, Drew P, Garmo H, Agbaje O, Pankhurst Q, Anninga B, Grootendorst M, Ten Haken B, Hall-Craggs MA, Purushotham A, Pinder S; SentiMAG Trialists Group. Sentinel node biopsy using a magn — View Citation
Ghilli M, Carretta E, Di Filippo F, Battaglia C, Fustaino L, Galanou I, Di Filippo S, Rucci P, Fantini MP, Roncella M. The superparamagnetic iron oxide tracer: a valid alternative in sentinel node biopsy for breast cancer treatment. Eur J Cancer Care (Eng — View Citation
Rubio IT, Diaz-Botero S, Esgueva A, Rodriguez R, Cortadellas T, Cordoba O, Espinosa-Bravo M. The superparamagnetic iron oxide is equivalent to the Tc99 radiotracer method for identifying the sentinel lymph node in breast cancer. Eur J Surg Oncol. 2015 Jan — View Citation
Thill M, Kurylcio A, Welter R, van Haasteren V, Grosse B, Berclaz G, Polkowski W, Hauser N. The Central-European SentiMag study: sentinel lymph node biopsy with superparamagnetic iron oxide (SPIO) vs. radioisotope. Breast. 2014 Apr;23(2):175-9. doi: 10.10 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Detection rate per Patient | Proportion of successfully detected sentinel nodes (detection rate per patient) with both methods. | During surgery | No |
Secondary | Number of lymph nodes excised | Number of excised sentinel lymph nodes | During surgery | No |
Secondary | Nodal detection rate | Number of detected versus excised sentinel lymph nodes with either method. | During surgery | No |
Secondary | Malignancy rate | Number of histologically confirmed malignant sentinel lymph nodes detected with either method. | 1-2 days post surgery | No |
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