Clinical trial NCT03038152: Magseed Magnetic Marker in Locating Axillary Lymph Nodes in Patients With Breast Cancer Undergoing Surgery
Official title: A Prospective, Open Label Study of the Use of Magseed® and Sentimag® to Localize Axillary Lymph Nodes With Biopsy-Proven Metastases in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breast Carcinoma Metastatic in Lymph Node
Stage II Breast Cancer AJCC v6 and v7
Stage IIA Breast Cancer AJCC v6 and v7
Stage IIB Breast Cancer AJCC v6 and v7
Stage IIIA Breast Cancer AJCC v7
Stage IIIB Breast Cancer AJCC v7
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-01-31
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This phase IV trial studies the side effects of the Magseed magnetic marker and how well it works in locating lymph nodes in the underarm area in patients with breast cancer undergoing surgery. Injecting a small metallic marker in or near the lymph node prior to surgery may help the surgeon locate the lymph nodes during surgery without using radiation.

Detailed description: PRIMARY OBJECTIVE:

I. To provide evidence that the clipped lymph node and Magseed can be successfully retrieved in the excised surgical specimen when Magseed and Sentimag are used for targeted axillary dissection in breast cancer patients.

OUTLINE:

Patients receive the Magseed marker via ultrasound guided injection into the previously clipped lymph node or within perinodal tissue =\< 3 mm from the clipped node. Patients then undergo axillary lymph node localization and targeted dissection within 30 days.

After completion of study, patients are followed up within 6-22 days post-surgery.

Eligibility criteria: Inclusion Criteria:

* 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 completing chemotherapy
* Received neoadjuvant chemotherapy prior to surgical resection
* Scheduled for targeted axillary dissection (defined as selective localization and removal of the clipped node and sentinel lymph node dissection \[SLND\])
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Exclusion Criteria:

* Distant metastases
* Inflammatory breast cancer
* Prior surgical axillary procedure including SLND or axillary node excision
* Prior history of breast cancer in the ipsilateral breast
* History of lymphoma
* The subject is known to be pregnant. Premenopausal patients under the age of 50 must have a pregnancy test performed as standard of care before the MagSeed is placed
* Previous radiation to the breast or axilla
* Pacemaker of other implantable device in the chest wall

Primary outcomes:
measure: Retrieval rate
timeFrame: Up to 15 months
measure: Incidence of adverse events
timeFrame: Up to 6 weeks post-procedure
Secondary outcomes:
measure: Radiologist rated ease of Magseed placement
timeFrame: Up to 15 months
measure: Accuracy of Magseed placement
timeFrame: Up to 15 months
measure: Surgeon rated ease of node localization and removal
timeFrame: Up to 15 months
measure: Number of nodes retrieved within the surgical specimen containing the Magseed
timeFrame: Up to 15 months
measure: Transcutaneous detection rate
timeFrame: Up to 15 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Abigail S Caudle
role: PRINCIPAL_INVESTIGATOR
References: