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Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors

NCT06049446 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2024-06-14

No results posted yet for this study

Summary

Rationale: Breast cancer patients are increasingly treated with neoadjuvant chemotherapy for various reasons. These women receive chemotherapy before any surgery is performed. Many of these tumors need preoperative seed localization to help guide the surgeons to the site of the tumor within the breast. The interest is shifting towards to use of non-radioactive seeds, such as the magnetic seeds used in this study. A drawback of these seeds is the fact that they cause large susceptibility artifacts on (magnetic!) MRI of the breast. Breast MRI is the most accurate modality to monitor response to therapy of these women. CEM, an emerging breast imaging technique, has shown to achieve comparable results with regard to response monitoring but uses no magnetic fields. Hence, CEM might be an attractive alternative response monitoring tool in patients treated with neoadjuvant chemotherapy and having a magnetic seed a surgical marker. To this point, however, no study in humans has confirmed that this is indeed the case.

Objective: To test whether the use of magnetic localization seeds causes image artifacts on CEM.

Study design: Observational feasibility study.

Study population: Women (\>18 years) able to provide written informed consent and recently diagnosed with (non-palpable) breast cancer or ductal carcinoma in situ (DCIS), who are primarily treated with surgery.

Intervention (if applicable): Image-guided placement of a magnetic seed (Sirius Pintuition) prior to surgery, including control imaging to confirm the correct location of the seed relative to the breast abnormality. In usual patient care this is performed with full-field digital mammography (FFDM), but in this study this control image will be performed with the system in 'contrast-enhanced mammography' or CEM mode, but without using intravenous administration of iodinated contrast agent because the purpose is not repetition of diagnostic imaging, but to rule out any artifacts caused by the seed on CEM. The investigators estimate to include twenty patients to confidently test the hypothesis that magnetic seeds do not cause disturbing artifacts on CEM examinations.

Main study parameters/endpoints: The primary study aim will be to test whether the magnetic seeds caused any disturbing artifacts on CEM images. As secondary study, the investigators will document technical success rate of seed deployment and retrieval during surgery, including the assessment of the surgical margins (positive or negative).

Conditions

Interventions

DEVICE

Pintuition

Magnetic seed localization

Sponsors & Collaborators

  • Zuyderland Medisch Centrum

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-08
Primary Completion
2024-06-10
Completion
2024-06-10
FDA Device
Yes

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06049446 on ClinicalTrials.gov