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Delayed Sentinel Lymph Node Biopsy for DCIS

This study is looking at a new way to identify if breast cancer has spread to the lymph nodes (small glands that are part of your immune system) in patients with ductal carcinoma in situ (DCIS) or other pre-invasive breast lesions. It's testing a method called delayed sentinel lymph node dissection (d-SLND) using superparamagnetic iron oxide (SPIO) nanoparticles. SPIO is injected during your initial breast surgery. If later tests show you have invasive breast cancer, the SPIO helps doctors find and remove the sentinel lymph nodes (the first lymph nodes where cancer cells are likely to spread) in a separate procedure. The study wants to see how well SPIO works compared to the standard method for finding these nodes. You might be able to join if you are a woman aged 18 or older with a preoperative diagnosis of DCIS, or if you are having a risk-reducing mastectomy or surgery for an unclear breast lesion.

Study design
This interventional study plans to enroll 500 women. It compares two methods for finding lymph nodes: delayed SLND using SPIO and late SLND using a radioisotope.
What's involved
Participants will have SPIO injected during their initial breast surgery. If invasive cancer is found later, they will undergo a second procedure to remove lymph nodes.
Compensation
Not stated in the trial record.
Follow-up
The main outcomes of the study, such as how well the lymph nodes are detected, are measured at the time of the operation.

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NCT04722692

Delayed Sentinel Lymph Node Biopsy in Ductal Cancer in Situ

Recruiting
PHASE3Ages 18+InterventionalTreatment
Uppsala University
~500 participants
Updated 2023-08-03 on ClinicalTrials.gov
What's tested:Delayed SLNDLate SLND

At a glance

Recruiting sites
9 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
d-SLND detection rate
Measured over One-time (At operation)
+2 more outcomes measured

Conditions

DCIS
Breast Cancer
Breast Neoplasms
Sentinel Lymph Node

Explore related trials

Breast Atypical Ductal HyperplasiaBreast CarcinomaBreast Ductal Carcinoma In SituBreast Lobular Carcinoma In Situ

Where it's being run

9 sites across 9 states
Texas1
Hong Kong1
Dalarna County1
Kronoberg County1
Skåne County1
Västmanland County1
Västra Götaland County1
Sweden1

Study leadership

  • Andreas Karakatsanis, PhD · PRINCIPAL_INVESTIGATOR · Uppsala University

Who to contact

Andreas Karakatsanis, PhD
[email protected]
+46765864826
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Intolerance/hypersensitivity to iron, dextran compounds or SPIO
An iron overload disease
Patient deprived of liberty or under guardianship
Pregnant or lactating patients

What this trial measures

  • d-SLND detection rateOne-time (At operation)

    Number of subjects in whom SPIO detected at least one node divided by the number of subjects who underwent the SLND procedure. Analyses will be performed cumulatively and +/-BD and per type of surgery (BCT or mastectomy).

  • l-SLND detection rateOne-time (At operation)

    Number of subjects in whom radioisotope detected at least one node divided by the number of subjects who underwent the SLND procedure. Analyses will be performed cumulatively and +/-BD and per type of surgery (BCT or mastectomy).

  • Nodal concordanceOne-time (At operation)

    Number of nodes identified by both test (SPIO) and control (isotope) out of all nodes identified. Analyses will be performed cumulatively and +/-BD and per type of surgery (BCT or mastectomy).