Breast Carcinoma Clinical Trial
Official title:
Targeted Axillary Dissection, Sentinel Biopsy, and Tumor Lesion Localization in Breast Cancer Patients Using the New Magnetic "Sentimag" Detection System
Verified date | January 2024 |
Source | University Hospital Ostrava |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The aim of this study is to compare the efficacy of the Sentimag localization system and its tracer Magtrace, superparamagnetic iron oxide nanoparticles, as a tracer in sentinel node biopsy in breast cancer with Tc99 in a single-center prospective study. The other part of the study will be the implantation of the smallest non-radioactive seed, Magseed, in the non-palpable breast cancer lesions. Another part of the study will be the implantation of Magseed in the positive axillary lymph nodes in patients diagnosed with clinically positive lymph nodes that will receive neoadjuvant systemic therapy.
Status | Completed |
Enrollment | 70 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Histologically confirmed cT0-4 breast cancer - Without/ With axillary lymph node metastasis with pathologic confirmation by needle biopsy - With/ without received neoadjuvant chemotherapy prior to surgical resection Exclusion Criteria: - Distant metastases - The subject is known to be pregnant - Pacemaker of another implantable device in the chest wall - Allergy to dextran or other iron-containing particles |
Country | Name | City | State |
---|---|---|---|
Czechia | University Hospital Ostrava | Ostrava | Moravian-Silesian Region |
Lead Sponsor | Collaborator |
---|---|
University Hospital Ostrava |
Czechia,
Greenwood HI, Wong JM, Mukhtar RA, Alvarado MD, Price ER. Feasibility of Magnetic Seeds for Preoperative Localization of Axillary Lymph Nodes in Breast Cancer Treatment. AJR Am J Roentgenol. 2019 Oct;213(4):953-957. doi: 10.2214/AJR.19.21378. Epub 2019 Jun 5. — 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;41(1):46-51. doi: 10.1016/j.ejso.2014.11.006. Epub 2014 Nov 15. — View Citation
Zacharioudakis K, Down S, Bholah Z, Lee S, Khan T, Maxwell AJ, Howe M, Harvey J. Is the future magnetic? Magseed localisation for non palpable breast cancer. A multi-centre non randomised control study. Eur J Surg Oncol. 2019 Nov;45(11):2016-2021. doi: 10.1016/j.ejso.2019.06.035. Epub 2019 Jun 26. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Accuracy of Magseed placement | Accuracy of Magseed placement will be measured regarding its position towards the lymph node in mm. Will be defined as accurate, marginal or inadequate. Descriptive statistics will be used to summarize accuracy of placement. Other statistical methods, when appropriate, may be used for analysis. | During the surgical procedure | |
Primary | Surgeon-rated ease of detected lymph node localization and removal | Descriptive statistics will be used to summarize surgeon rated ease of localization. | During the surgical procedure | |
Primary | Number of nodes retrieved within the surgical specimen containing the Magseed | Descriptive statistics will be used to summarize number of nodes retrieved within the surgical specimen containing the Magseed. | During the surgical procedure | |
Primary | Surgeon-rated ease of detected labeled lesion localization and removal | Descriptive statistics will be used to summarize number of nodes retrieved within the surgical specimen containing the Magseed. | During the surgical procedure | |
Primary | Transcutaneous detection rate | Descriptive statistics will be used to summarize transcutaneous detection rate. | During the surgical procedure | |
Primary | Incidence of adverse events | Toxicity data will be summarized by frequency tables. For the toxicity endpoint, per-treated analysis will be used to include any patient who received the treatment regardless of the eligibility nor the duration or dose of the treatment received. | Up to 6 weeks post-procedure |
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