A way to avoid unnecessary sentinel node biopsies in patients with ductal cancer in situ

• Register: ISRCTN
• Last refreshed on: 25 March 2019
• Main ID: ISRCTN18430240
• Date of registration: 15/11/2016
• Prospective Registration: No
• Primary sponsor: Uppsala University
• Public title: A way to avoid unnecessary sentinel node biopsies in patients with ductal cancer in situ
• Scientific title: The use of superparamagnetic iron oxide particles as a tracer to avoid unnecessary sentinel node biopsies in patients with a preoperative diagnosis of ductal cancer in situ
• Date of first enrolment: 01/05/2015
• Target sample size: 300
• Recruitment status: Recruiting
• URL: http://isrctn.com/ISRCTN18430240
• Study type: Observational
• Study design: Prospective single-arm observation cohort (Diagnostic)
• Phase: Not Applicable

Countries of recruitment

Sweden

Contacts

• Name: Andreas Karakatsanis

Key inclusion & exclusion criteria

Inclusion criteria:
1. Patients with a preoperative diagnosis of DCIS grade 3 any size or, DCIS grade 2 larger than 20 mm on mammography and planned for breast conserving surgery (BCS)
2. Patients with a preoperative diagnosis of DCIS, any grade and any size, planned for mastectomy

Exclusion criteria:
1. Patients undergoing a direct reconstruction with autologous tissue
2. Intolerance/hypersensitivity to iron or dextran compounds or Sienna+
3. Patients with an iron overload disease
4. Patients with pacemakers or other implantable devices in the chest-wall, or prosthesis in the shoulder
5. Patient deprived of liberty or under guardianship
6. Pregnant or lactating patients


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Ductal Cancer in Situ (DCIS)
Cancer
Breast cancer

Intervention(s)

Sienna+ (2ml + NaCl 3ml) will be injected in association with the primary breast surgery on patients with a preoperative diagnosis of DCIS. The Sienna+ is injected close to the tumour, subcutaneously. The sentinel node (SN) is uploaded with Sienna+ but is not removed. The counts by SentiMag is measured transcutanously at the end of the procedure.

The patient is scheduled for a visit to the breast unit within 2 weeks after surgery. If there is an invasive tumour component on the final histopathological examination, a sentinel node biopsy (SNB) will be performed at a second operation within 1-2 weeks. A preoperative injection of radioisotope will be made to maximize the chance to detect the SN.

This SNB will start with a registration of the magnetic- and isotope signal in the axilla, and the incision will be placed in relation to the signal. If no activity is measured, an injection of 1 ml Patent Blue Dye will be made in the area of the breast where the tumour was located. After a sufficient waiting time, 5-10 minutes, a small incision will be made in the lower part of the axilla, and careful dissection will be made to identify lymphatic vessels and lymph nodes. After a mastectomy, the lateral part of the earlier incision is used. If no SN is found, an axillary clearance or sampling will follow, according to the surgeon's decision. The SN will be sent for frozen section in order to avoid a third operation if SN metastases are present.

Primary Outcome(s)

Number of SNB procedures spared, defined as those cases of patients with a definite postoperative diagnosis of pure DCIS in whom no SNB will be performed

Secondary Outcome(s)

SNB detection rate in a second operation, defined as the number of successful SNBs for each patient and for each method (SPIO, isotope and blue dye) divided by the total amount of SNBs performed

Secondary ID(s)

SentiNot

Source(s) of Monetary Support

Uppsala Universitet

Ethics review

Status:
Approval date:
Contact:

Uppsala University Ethics Committee, 13/04/2015, ref: 2014:073

Results

• Results available: Yes
• Date Completed: 30/08/2021