Clinical trial · Observational
Delayed SLND for Patients With Breast Cancer Undergoing Primary Systemic Treatment
A Feasibility Study on the Timeframe of Superparamagnetic Iron Oxide Nanoparticles Administration in Patients Receiving Primary Systemic Therapy for Early Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this study was to assess the feasibility of SLND by superparamagnetic iron oxide nanoparticles (SPIO) in patients with early breast cancer planned for primary systemic therapy (PST) and whether this is affected by the timeframe of SPIO administration. For this, patients with cN0/1 disease planned for PST received radioisotope as per routine on the day of surgery or the day before, and SPIO was injected in an extended timeframe, at any point from the day of surgery to before the induction of PST. The main points to investigate are: 1. If the SPIO detection rate and concordance to the radiosotope are affected by time of SPIO injection 2. If the nodal yield and the accuracy of the procedure are affected
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Chemotherapy Effect | — | UNRESOLVED | — |
| Sentinel Lymph Node | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SLND or TAD by the magnetic technique (SPIO) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Correlation between concordance (isotope and SPIO) and timepoint of SPIO administration to surgery
- timeFrame
- At surgery
- description
- This endpoint is necessary in ensuring that prolonged SPIO administration does not result in the retrieval of "false" SLNs, in the case that SPIO migrates to higher nodal echelons. As the radioisotope is the current standard of care, the concordance of SPIO to the radioisotope and its correlation with time of SPIO adminstration is the appropriate surrogate endpoint.
- measure
- Detection rate
- timeFrame
- At surgery
- description
- The successful retrieval of at least one SLN detected by each tracer (SPIO or radioisotope) separately.
- measure
- Concordance
- timeFrame
- At surgery
- description
- The rate (patients with at least one SLN detected with both tracers/patients with at least one SLN detected with the radioisotope)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients with non-metastatic primary breast cancer and cN0/cN1 axilla, as defined by clinical examination and axillary ultrasound (with fine needle aspiration or core biopsy verification of metastasis) intended for PST (chemotherapy, targeted treatment or endocrine therapy) with a curative intention at diagnosis, Exclusion Criteria: * Distant metastases at diagnosis * Inflammatory breast cancer * Tumor progression during PST for cN1 patients * ycN1 after completion of PST * surgery before the completion of PST for any reason (PST adverse effects, patient preference) * cN1-to-ycN0 patients that opted for ALND
References
Publications (0)
Data not yet available