Magtrace for DCIS

Overseen By Carol Tunsil

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Florida

Disqualifiers: Invasive breast cancer, Chemotherapy, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach called Magtrace for individuals with non-invasive ductal carcinoma in situ (DCIS), a type of breast cancer. The goal is to determine if Magtrace can help avoid unnecessary sentinel lymph node biopsies, typically performed during mastectomy to check for cancer spread. Magtrace is a special agent that remains in the lymph nodes for weeks, allowing doctors to delay the biopsy until necessary. This trial suits those diagnosed with DCIS who plan to undergo a mastectomy and have had a clear pre-operative axillary ultrasound. As a Phase 2 trial, this research measures how well Magtrace works in an initial, smaller group, offering participants a chance to contribute to significant advancements in breast cancer treatment.

What prior data suggests that Magtrace is safe for use in lymphatic mapping?

Research shows that Magtrace, an iron-based agent used to map lymph nodes, is safe and well-tolerated in people. Studies have demonstrated its effectiveness and reliability for staging breast cancer. Magtrace stays in the lymph nodes for up to four weeks, aiding accurate mapping and allowing for a possible delayed biopsy. Importantly, recent studies confirm its safety for delayed sentinel lymph node biopsy, with no major side effects reported. For patients with ductal carcinoma in situ (a very early form of breast cancer), Magtrace offers a safe alternative to traditional methods, reducing unnecessary procedures. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Magtrace is unique because it offers a new way to identify sentinel lymph nodes in patients with ductal carcinoma in situ (DCIS). Unlike traditional methods that rely on radioactive tracers or blue dyes, Magtrace employs superparamagnetic iron oxide particles. This magnetic approach promises a safer and more precise method of detection with fewer side effects. Researchers are excited about Magtrace because it could simplify the process, reduce radiation exposure, and improve accuracy in lymph node mapping, potentially enhancing surgical outcomes for patients.

What evidence suggests that Magtrace is effective for DCIS?

Research has shown that Magtrace, a special iron-based substance, might help patients with ductal carcinoma in situ (DCIS) avoid unnecessary surgeries. In this trial, participants will receive a Magtrace injection. Unlike traditional methods, Magtrace remains in the lymph nodes for up to four weeks, allowing doctors to accurately map them even after breast removal surgery. Studies indicate that Magtrace is as effective at locating lymph nodes as the usual method. This could reduce the need for an immediate sentinel lymph node biopsy (SLNB), which often proves unnecessary. Additionally, using Magtrace may lower overall treatment costs. Early findings suggest Magtrace is a promising option for patients undergoing surgery for DCIS. ^{2 5 6 7 8}

Who Is on the Research Team?

Jennifer Fieber, MD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

This trial is for patients with a diagnosis of ductal carcinoma in-situ (DCIS), Stage 0 breast cancer, who are planning to undergo mastectomy. They must consent to study procedures and if of childbearing potential, have a negative pregnancy test preoperatively.

Inclusion Criteria

I have been diagnosed with Stage 0 breast cancer and plan to have a mastectomy.

I have taken a pregnancy test before surgery, and it was negative.

I have signed the consent form and agree to follow the study rules.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Mastectomy and Magtrace Injection

Participants undergo mastectomy and receive Magtrace injection for lymphatic mapping

At the time of mastectomy

Delayed Sentinel Lymph Node Biopsy

Participants may return for a delayed sentinel lymph node biopsy if invasive cancer is found

Up to 24 months post-mastectomy

Follow-up

Participants are monitored for safety and effectiveness, including patient-reported outcomes

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Magtrace

Trial Overview

The trial is testing Magtrace, an iron-based agent that maps lymph nodes for at least 4 weeks. It aims to see if using Magtrace allows delayed sentinel lymph node biopsy (SLNB) and avoids unnecessary SLNBs at the time of mastectomy for DCIS.

How Is the Trial Designed?

Group I: Magtrace injection Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11522053/

Cost containment analysis of superparamagnetic iron ...

The use of Magtrace® for delayed SLNB in patients with DCIS undergoing mastectomy yielded a significant overall cost containment, further supporting its use in ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06868238

Evaluation of Novel Iron-based Lymphatic Mapping Agent ...

This study will investigate whether the use of Magtrace will successfully allow patients with DCIS undergoing mastectomy to avoid undergoing SLNB. Official ...

3.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf16/P160053S002B.pdf

Summary of Safety and Effectiveness Data (SSED)

The trial was designed to provide powered evidence that the lymph node detection rate of the Magtrace®/Sentimag® system is non-inferior to the standard of care ...

4.

researchgate.net

researchgate.net/publication/347289971_A_Pilot_Study_Evaluating_the_Effects_of_MagtraceR_for_Sentinel_Node_Biopsy_in_Breast_Cancer_Patients_Regarding_Care_Process_Optimization_Reimbursement_Surgical_Time_and_Patient_Comfort_Compared_With_S

(PDF) A Pilot Study Evaluating the Effects of Magtrace® for ...

The primary outcomes were time spent on the care pathway and operating time from commissioning of the probe to removal of the sentinel node. The ...

5.

abs.amegroups.org

abs.amegroups.org/article/view/8865/html

Comparative analysis of sentinel lymph node localization ...

Our study aims to evaluate Magtrace's effectiveness, focusing on feasibility and patient satisfaction, potentially offering a more efficient approach.

6.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf16/P160053B.pdf

summary of safety and effectiveness data (ssed)

The analysis of this study provides valid scientific evidence to support the effectiveness of Magtrace™/Sentimag® which can be considered clinically and ...

7.

endomag.com

endomag.com/resources/clinical-data/tracer/

Magtrace® Clinical Data

Explore the latest clinical data and evidence supporting the use of Magtrace® for safe and reliable breast cancer staging.

8.

endomag.com

endomag.com/patients/delayed-slnb-with-magtrace-patient-guide/

Delayed Sentinel Lymph Node Biopsy with Magtrace®

Ductal carcinoma in-situ (DCIS) is considered the earliest form of breast cancer. It occurs when abnormal cells appear inside a milk duct in the breast, ...