Mastectomy Clinical Trials

Clinical trials related to Mastectomy Procedure

Evaluation of Novel Iron-based Lymphatic Mapping Agent, Magtrace, for Delayed Sentinel Lymph Node Biopsy (SLNB) in Ductal Carcinoma In-Situ (DCIS)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The standard surgical approach for all patients undergoing mastectomy for the treatment of non-invasive, ductal carcinoma in situ (DCIS) is to perform axillary lymph node staging through use of a traditional sentinel lymph node biopsy (SLNB) procedure where the lymph nodes that drain the breast first are removed at the time of mastectomy. This recommendation for traditional SLNB is due to the risk of finding invasive cancer during surgical evaluation of the mastectomy specimen and the inability to accurately map the lymphatic channels once the breast is removed. In a study by Herremans et al, the majority of traditional SLNBs were demonstrated to be unnecessary. By using Magtrace, a novel iron based lymphatic mapping agent, a delayed SLNB could eliminate these unnecessary traditional SLNBs. Magtrace, or superparamagnetic oxide (SPIO), was developed in 2018. Unlike traditional mapping agents of blue dye and technetium that clear the body within 24-48 hours, Magtrace remains in the lymph nodes for at least 4 weeks. Magtrace's ability to remain in the lymph node allows accurate mapping of the lymph nodes at the time of the mastectomy with the ability to return to the operating room for a delayed sentinel lymph node biopsy if invasive cancer is found on final pathology. This study will investigate whether the use of Magtrace will successfully allow patients with DCIS undergoing mastectomy to avoid undergoing SLNB.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adults ≥ 18 years of age.

• Patients with a core needle biopsy diagnosis consistent with ductal carcinoma in-situ (DCIS), Stage 0 breast cancer, who are planning to undergo a mastectomy.

• o The mastectomy can be with or without reconstruction and with or without contralateral prophylactic mastectomy.

• Patients with a negative pre-operative axillary ultrasound.

• For subjects of childbearing potential, a pregnancy test that has resulted as negative is required preoperatively.

• Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures.

Locations
United States
Florida
University of Florida
RECRUITING
Gainesville
Contact Information
Primary
Carol Tunsil
caroltunsil@ufl.edu
352-392-5347
Time Frame
Start Date: 2026-02
Estimated Completion Date: 2029-06
Participants
Target number of participants: 30
Treatments
Experimental: Magtrace injection
Related Therapeutic Areas
Sponsors
Leads: University of Florida

This content was sourced from clinicaltrials.gov