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

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.

Study Overview

• Status: Recruiting
• Conditions: Ductal Carcinoma in Situ
• Intervention / Treatment: Drug: Magtrace

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Stephanie Portillo; Phone Number: 352-273-3650; Email: portillos@ufl.edu

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32608
      • Recruiting
      • University of Florida
      • Principal Investigator: Lisa Spiguel, MD
      • Contact: Stephanie Portillo; Phone Number: 352-273-3650; Email: portillos@ufl.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Patients with contralateral invasive breast cancer requiring traditional sentinel lymph node biopsy at time of index operation or additional chemotherapy that may have been omitted for DCIS.
• Any history of receiving chemotherapy
• Prior ipsilateral breast cancer with treatment that included radiation, lumpectomy, chemotherapy, or sentinel lymph node biopsy.
• Ipsilateral prior axillary sentinel lymph node biopsy for other malignancy (i.e., melanoma).
• Patients with a history of upper extremity blood clot, lymphangitis/cellulitis, lymphedema, or those who use a pacemaker device
• Patients with an allergy to iron, dextran, or any other ingredient in Magtrace.
• Patients with an abnormal pre-operative axillary ultrasound.
• Subjects who are confirmed to be pregnant.
• History of any other disease, metabolic dysfunction, clinical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician.
• Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Magtrace injection	Drug: Magtrace; Participants will receive a single injection of Magtrace into the breast during their mastectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients with DCIS who do not undergo sentinel lymph node biopsy	Determine the percentage of patients with DCIS who do not undergo sentinel lymph node biopsy.	24 months post-mastectomy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients that are found to have invasive disease at time of mastectomy	Determine the Percentage of patients that are found to have invasive disease at time of mastectomy.	At the time of mastectomy
Rate of return to operating room for delayed sentinel lymph node biopsy	Determine the number of patients who return to the operating room for delayed sentinel lymph node biopsy.	24 months post-mastectomy
Patient-reported outcomes measures	Compare the scores obtained to the historical control for each of the following scales of the Breast-Q questionnaire: psychosocial well-being, sexual well-being, cancer worry, fatigue, and impact on work.	24 months post-mastectomy

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Lisa Spiguel, MD, University of Florida

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: March 6, 2025
• First Submitted That Met QC Criteria: March 6, 2025
• First Posted (Actual): March 10, 2025

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: breast; lymphedema; mastectomy; sentinel lymph node biopsy; ductal carcinoma in situ; superparamagnetic oxide (SPIO/Magtrace)
• Additional Relevant MeSH Terms: Breast Carcinoma In Situ; Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Lymphatic Diseases; Carcinoma; Neoplasms, Ductal, Lobular, and Medullary; Carcinoma in Situ; Hemic and Lymphatic Diseases; Lymphedema; Carcinoma, Intraductal, Noninfiltrating
• Other Study ID Numbers: UF-BRE-014

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No