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

NCT06049446 | Completed FDA Device

• 1 other identifier: CEMMAG
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Breast Cancer

Keywords

Breast neoplasms; Mammography

Outcome Measures

Primary Outcomes (2)

• Assessment of image artifacts

  Main study endpoint will be the assessment of the occurrence of image artifacts, which will be scored by blinded radiologists in the following way: if there are any artifacts present in the image (yes/no) and caused by the magnetic seed

  1 day

• Influence of image artifacts

  If primary outcome measure #1 is answered with yes: are the artifacts influencing the overall image quality (yes/no)?

  1 day

Secondary Outcomes (3)

• Technical success rate of seed deployment

  1 month

• Technical success rate of see retrieval during surgery

  1 month

• Surgical outcome

  1 month

Study Arms (1)

Patients receiving seed localization

Patients receiving seed localization

Device: Pintuition

Interventions

Pintuition DEVICE

Magnetic seed localization

Patients receiving seed localization

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female with breast cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

For this purpose, women meeting the inclusion criteria (see paragraph 4.2) will be asked to participate in this study. If they consent, the regular localization using a I-125 marker will be replaced by the magnetic seed, but the remainder of the procedure of implantation is identical (image guided placement using local anesthesia). Normally, a conventional (full-field digital) mammogram is acquired to establish the (correct) position of the marker with respect to the lesion of interest. For this study, we will select the 'CEM' mode instead of 'FFDM' mode on the mammography unit. This will result in having a standard CEM examination. Since the images are intended to check for artifacts caused by the seed, we decided not to administrate iodinated contrast agent to reduce patient's burden (as this would require catheter placement and contrast administration, potentially resulting in complications such as infection, hematoma, and hypersensitivity reactions to the contrast used). A low-ener

You may qualify if:

• Included are non-pregnant women (\>18 years of age),
• Recently diagnosed with non-palpable invasive breast cancer or DCIS, requiring primary surgical treatment.
• Only women able to provide written informed consent will be considered for this study.

Sponsors & Collaborators

• Zuyderland Medisch Centrum: lead

Study Sites (1)

Zuyderland Medical Center

Sittard, Limburg, 6162BG, Netherlands

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: September 22, 2023
• Study Start: September 8, 2023
• Primary Completion: June 10, 2024
• Study Completion: June 10, 2024
• Last Updated: June 14, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)