Delayed Lymph Node Biopsy for Ductal Cancer in Situ
Delayed Sentinel Lymph Node Biopsy in Ductal Cancer in Situ
Recruiting
Phase 3
Interventional Study
DCIS
Breast Cancer
Breast Neoplasms
Sentinel Lymph Node
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 500 (estimated)
- Sponsor
- Uppsala University · Other
Who this trial is looking for
This trial is looking for women who have a type of breast cancer called ductal carcinoma in situ (DCIS). Participants will receive a special injection and may undergo extra surgery only if their cancer is found to be invasive after an initial procedure.
Are You a Good Fit for This Trial?
You may be able to join if
- I have been diagnosed with ductal carcinoma in situ (DCIS).
- I am planning to have a mastectomy to reduce my cancer risk.
- I have a pre-invasive or unclear breast lesion.
- I have a grade 3 DCIS or a grade 2 DCIS that is 20 mm or larger.
- I have a palpable mass or mass effect on imaging.
- I have a suspicion of micro-invasion based on a biopsy.
- I have a suspicious finding on imaging planned for diagnostic surgery.
- I have a diagnosis of pleomorphic lobular cancer in situ or atypical ductal hyperplasia.
You may not be able to join if
- I am allergic to iron or related compounds.
- I have an iron overload disease.
- I am currently in custody or under guardianship.
- I am pregnant or breastfeeding.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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About This Trial
The trial aims to investigate the use of superparamagnetic iron oxide (SPIO) nanoparticles as a tracer for delayed sentinel lymph node dissection (d-SLND) in patients where upfront axillary surgery (SLND) is oncologically deemed unnecessary and should be avoided. This includes but is not limited to patients with a preoperative diagnosis of ductal cancer in situ of the breast (DCIS), an unclear BIR…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
A. Preoperative diagnosis of DCIS, of any grade and any size if planned for mastectomy.
B. Planned Risk-reducing mastectomy, if it would be considered for upfront SLND due to institutional practice or in case of an individualised recommendation.
C. Any case with a preoperative…
Contacts