Clinical trial NCT03796559: Magseed Enabled Long-Term Localization of Axillary Lymph Nodes
Official title: A Prospective Open Label Study of the Use of Magseed® Markers and Sentimag® to Localize Axillary Lymph Nodes with Biopsy-proven Metastases in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Axillary Lymph Nodes
Keywords: Neo-adjuvant chemotherapy
Lead sponsor: Endomagnetics Ltd.
Sponsor class: INDUSTRY
First posted: 2019-01-08
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to provide prospective evidence that the use of Magseed/Sentimag in marking axillary lymph nodes and guiding surgical localization in patients with breast cancer following neo-adjuvant chemotherapy (NAC) is effective.

Detailed description: This is a post-market, prospective, open-label, single arm study of Magseed and Sentimag in patients with breast cancer with biopsy-proven axillary node metastases who had a clip placed to mark the metastatic node and are having that clipped node selectively removed at surgery following neo-adjuvant chemotherapy (NAC). Subjects will have the Magseed placed to mark axillary lymph nodes with biopsy-proven metastasis under ultrasound guidance before initiating NAC. After completion of NAC, the Magseed will be localized using the Sentimag system during surgery and removed with the targeted lymph node.

Eligibility criteria: Inclusion Criteria:

* Age 18 years or older at time of consent
* Histologically confirmed cT0-4, N1 breast cancer
* Axillary lymph node metastasis with pathologic confirmation by needle biopsy
* Clip placed in the sampled axillary lymph node before initiation of chemotherapy
* Planned for neo-adjuvant chemotherapy prior to surgical resection
* Eligible for targeted axillary dissection (defined as selective localization and removal of the clipped node and SLND) at the completion of neo-adjuvant chemotherapy
* ECOG performance status 0-2

Exclusion Criteria:

* Distant metastases
* Inflammatory breast cancer
* Prior ipsilateral axillary surgical procedure including SLND or axillary node excision
* Prior history of breast cancer in the ipsilateral breast
* History of lymphoma
* Subject is pregnant
* Previous radiation to the breast or axilla
* Pacemaker or other implantable cardiac device in the ipsilateral chest wall

Primary outcomes:
measure: Retrieval rate of clipped node and Magseed in the excised specimen
timeFrame: Time of surgery
Secondary outcomes:
measure: Rates of device and serious device-related events
timeFrame: Up to 42 days post-surgery
measure: Radiologic rated ease of Magseed placement
timeFrame: Time of Magseed marker placement
measure: Radiologic placement accuracy
timeFrame: Between completion of NAC time of surgery
measure: Radiologic seed position
timeFrame: After completion of NAC
measure: Surgical nodes localized
timeFrame: Time of surgery
measure: Ease of surgical localization
timeFrame: Time of surgery
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor Medicine
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: MD Anderson Cancer Center, Houston, TX
name: Abigail Caudle, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: