Recruiting
Phase 3

Observational Study

Sponsor:

Uppsala University

Code:

NCT04722692

Conditions

DCIS

Breast Cancer

Breast Neoplasms

Sentinel Lymph Node

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Delayed SLND

Late SLND

Study Details

Brief summary:

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.

Conditions

DCIS

Breast Cancer

Breast Neoplasms

Sentinel Lymph Node

Study ID

NCT04722692

Start date

Mar 1, 2020

Status verified date

Aug, 2023

Completion date

Dec 30, 2027

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Delayed SLND (SPIO-first arm)

All study participants have been injected interstitially with SPIO, 2ml, at the primary operation. Magnetic axillary signal is registered at the end of the procedure but the SLN is not removed. If invasive cancer is found in the specimen, reoperation for SLND with the addition of Tc +/- BD is performed.

At reoperation, SPIO is the "primary" detection tracer.

active comparator: Late SLND (RI-first arm)

All study participants have been injected interstitially with SPIO, 2ml, at the primary operation. Magnetic axillary signal is registered at the end of the procedure but the SLN is not removed. If invasive cancer is found in the specimen, reoperation for SLND with the addition of Tc +/- BD is performed.

At reoperation, Tc is the "primary" detection tracer.

Interventions

Delayed SLND

SLND performed after surgery for DCIS or other pre-invasive lesions, where final pathology showed invasive breast cancer. Patients have received SPIO in the breast at the first operation, prior to dissection and resection and the SLN has already been marked with SPIO. These SLNs are to be removed.

SLND is divided into the following steps:

1. Transcutaneous signal
2. Incision in the axilla (skin, subcutaneous fat and fascia) and "In situ" signal
3. SLN identification "in situ"
4. SLN excision and signal "ex vivo"
5. Background axillary counts. For step "d" the radioactive counts are registered for each SLN that has been excised. When the procedure is completed successfully with SPIO, then background axillary isotope counts are registered and, if present, SLND continues as described above with the isotope as primary tracer.

Late SLND

SLND performed after surgery for DCIS or other pre-invasive lesions, where final pathology showed invasive breast cancer. Patients will be injected with radioisotope in the operated breast before SLND according to standard of care. Any SLNs detected with this intervention are to be removed.

SLND is divided into the following steps:

1. Transcutaneous signal
2. Incision in the axilla (skin, subcutaneous fat and fascia) and "In situ" signal
3. SLN identification "in situ"
4. SLN excision and signal "ex vivo"
5. Background axillary counts. For step "d" the magnetic counts are registered for each SLN that has been excised. When the procedure is completed successfully with the isotope, then background axillary iSPIO counts are registered and, if present, SLND continues as described above with the SPIO as primary tracer.

Primary outcome measure

  • d-SLND detection rate [ Time Frame: One-time (At operation) ]
  • l-SLND detection rate [ Time Frame: One-time (At operation) ]
  • Nodal concordance [ Time Frame: One-time (At operation) ]

Central Contacts and Locations

Central contacts

Andreas Karakatsanis, PhD

+46765864826andreas.karakatsanis@surgsci.uu.se

Fredrik Wärnberg, PhD

fredrik.warnberg@vgregion.se

Locations

Baylor College Of Medicine

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

Uppsala University

Last update posted

Aug 3, 2023

Last verified

Aug, 2023

Keywords

  • Sentinel Lymph Node Dissection
  • DCIS; Ductal Cancer In situ of the breast
  • Breast cancer
  • Superparamagnetic Iron Oxide Nanoparticles
  • Sentinel Lymph Node
  • Risk reducing mastectomy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Uppsala University on 2023-08-03.