Delayed Sentinel Lymph Node Biopsy in Ductal Cancer in Situ
Sentinel Lymph Node Biopsy in Ductal Cancer in Situ or Unclear Lesions of the Breast and How to Not do it. An Open-label, Phase 3, Randomised Controlled Trial. (SentiNot 2.0).
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Biopsies, Injections
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "The SentiNot 2.0 protocol aims to elucidate the effectivity and accuracy of the delayed sentinel lymph node dissection concept (dSLND) when upfront SLND is considered unnecessary, such as in the setting of a preoperative diagnosis of DCIS, in cases of unclear BIRADS 4 or 5 lesions that are planned for diagnostic excisional biopsy or in selected cases of risk reducing mastectomy."
- "A preoperative injection of radioisotope (RI) RI will be added to maximize the chance to detect the SLN."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests tiny iron particles called SPIO to help find lymph nodes if surgery to check them is needed later. It is for people who do not need underarm lymph node surgery at first, including those with DCIS, cancer that stays inside the breast’s milk ducts. SPIO is injected during the first breast surgery; underarm lymph nodes are removed later only if lab tests find cancer that has grown beyond where it started.
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 BIRADS 4-5 planned for diagnostic excision or women planned for risk reducing mastectomy. SPIO is injected in the primary operation, and should final specimen pathology demonstrate invasive breast cancer, only then is an operation in the axilla (d-SLND) performed.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- DCIS of any grade or size, with a planned mastectomy (surgery to remove the breast).
- Planned breast removal to lower cancer risk, when early lymph node surgery would usually be done or has been advised for you.
- A breast change that has not become invasive cancer, or whose diagnosis is unclear, when early lymph node surgery would otherwise be considered. Examples follow.
- DCIS with planned surgery that keeps the breast: grade 3 of any size, or grade 2 measuring at least 20 mm on a mammogram. Grade describes how abnormal the cells look.
- DCIS found on a needle biopsy, with a lump felt during an exam, a mass seen on a scan, or signs that cancer may have just begun to spread beyond the milk ducts.
- A suspicious breast scan rated BI-RADS 4 or 5, with planned surgery to remove and test the area while keeping the breast, but no confirmed invasive cancer.
- DCIS of any grade or size, with planned complex breast removal and reshaping surgery, or surgery that may make lymph nodes harder to find later.
- The situations above may also apply to pLCIS, classic lobular neoplasia, or ADH—other types of abnormal cells in the breast’s milk glands or ducts.
Who can't join
- An allergy or intolerance to iron, dextran compounds, or SPIO.
- A disease that causes too much iron to build up in the body.
- Being held in custody or under legal guardianship.
- Pregnant or breastfeeding.
Simplified for readability. The official criteria below are what the study team uses.
Official 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 diagnosis of pre-invasive or unclear lesion, that upfront SLND would be otherwise considered, such as, but not limited to: * Patients with a preoperative diagnosis of DCIS grade 3 any size or, DCIS grade 2 larger than or equal to 20 mm on mammography and planned for breast conserving surgery or * Patients with a preoperative diagnosis of DCIS on core biopsy with a palpable mass on clinical examination or mass effect on radiology or * Patients with a preoperative diagnosis of DCIS with suspicion of micro-invasion on core biopsy or * Patients with a mammographic/ultrasound/MRI finding, suspicious for breast cancer (BIRADS 4 or 5) planned for diagnostic excision with breast conserving surgery, with no definitive diagnosis of invasive cancer or * Patients with a preoperative diagnosis of DCIS, any grade, any size and planned for a complex oncoplastic procedure or * Patients with a preoperative diagnosis of DCIS, any grade, any size and planned for a procedure that may compromise detection rate for a future SLND, such as, but not confined to: lesions in the upper outer quadrant or the axillary tail, removal of the nipple areola complex and so on or * The above mentioned categories with a preoperative diagnosis of pleomorphic Lobular Cancer in Situ (pLCIS), classic Lobular Neoplasia (LN) or Atypical Ductal Hyperplasia (ADH). Exclusion Criteria: * Intolerance/hypersensitivity to iron, dextran compounds or SPIO * An iron overload disease * Patient deprived of liberty or under guardianship * Pregnant or lactating patients
Study sites (1)
TX
- Baylor College Of Medicine · Houston, TX 77030Alastair Thompson · Study contactMore trials in Houston