Trials / Completed
CompletedNCT03038152
Magseed Magnetic Marker in Locating Axillary Lymph Nodes in Patients With Breast Cancer Undergoing Surgery
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
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 54 (actual)
- Sponsor
- M.D. Anderson Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Axillary Lymph Node Dissection | Undergo targeted axillary lymph node dissection |
| PROCEDURE | Localization | Undergo axillary lymph node localization |
| DEVICE | Medical Device | Receive Magseed via ultrasound guided injection |
Timeline
- Start date
- 2017-04-11
- Primary completion
- 2021-03-01
- Completion
- 2021-03-01
- First posted
- 2017-01-31
- Last updated
- 2021-03-05
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03038152. Inclusion in this directory is not an endorsement.