New dye could spare thousands of women from unnecessary lymph node removal
NCT ID NCT06868238
First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 3 times
Summary
This study tests a new dye called Magtrace that stays in the lymph nodes for weeks. For women with non-invasive breast cancer (DCIS) having a mastectomy, this dye may allow doctors to safely delay lymph node removal until after the breast tissue is checked for hidden invasive cancer. The goal is to avoid unnecessary lymph node surgery in most patients.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Florida
Gainesville, Florida, 32608, United States
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Other studies related to the condition(s) this trial covers.
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