Ductal Carcinoma in SituPhase 2NCT06868238
Evaluation of Novel Iron-based Lymphatic Mapping Agent, Magtrace, for Delayed Sentinel Lymph Node Biopsy (SLNB) in Ductal Carcinoma In-Situ (DCIS)
A Phase 2 study testing Magtrace in people with Ductal Carcinoma in Situ, run by University of Florida at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ductal Carcinoma in Situ
- What is being tested?
- Magtrace
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Jun 2029
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Ductal Carcinoma in Situ
- Being tested
- Magtrace
- Keywords
- ductal carcinoma in situ, superparamagnetic oxide (SPIO/Magtrace), sentinel lymph node biopsy, mastectomy, breast, lymphedema
- Medical subject headings
- Carcinoma, Intraductal, Noninfiltrating, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagtraceDrug
Participants will receive a single injection of Magtrace into the breast during their mastectomy.
| Study group | Role | What they receive |
|---|---|---|
| Magtrace injection | Experimental | Not described Receives: Drug: Magtrace |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months post-mastectomy
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 24 months post-mastectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study startOct 2026 (estimated)
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (estimated)
Why it stopped: Major protocol revision involving eligibility criteria and screening procedures in progress
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ductal Carcinoma in SituStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa Spiguel, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06868238
- Sponsor's protocol ID
- UF-BRE-014
- Status last verified
- Sep 2026
- First submitted
- 6 Mar 2025
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Novel Iron-based Lymphatic Mapping Agent, Magtrace, for Delayed Sentinel Lymph Node Biopsy (SLNB) in Ductal Carcinoma In-Situ (DCIS)
- ClinicalTrials.gov ID
- NCT06868238
- Acronym / sponsor ID
- UF-BRE-014
- Conditions
- Ductal Carcinoma in Situ
- Keywords
- ductal carcinoma in situ, superparamagnetic oxide (SPIO/Magtrace), sentinel lymph node biopsy, mastectomy, breast, lymphedema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Major protocol revision involving eligibility criteria and screening procedures in progress
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Magtrace injection | Experimental | Drug: Magtrace |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MagtraceParticipants will receive a single injection of Magtrace into the breast during their mastectomy. | Drug | Magtrace injection |
Primary outcome
Percentage of patients with DCIS who do not undergo sentinel lymph node biopsy
Time frame: 24 months post-mastectomy
Determine the percentage of patients with DCIS who do not undergo sentinel lymph node biopsy.
3 secondary outcomes
Percentage of patients that are found to have invasive disease at time of mastectomy
Time frame: At the time of mastectomy
Rate of return to operating room for delayed sentinel lymph node biopsy
Time frame: 24 months post-mastectomy
Patient-reported outcomes measures
Time frame: 24 months post-mastectomy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Spiguel, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Magtrace in people with Ductal Carcinoma in Situ, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with DCIS who do not undergo sentinel lymph node biopsy (time frame: 24 months post-mastectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.