A way to avoid unnecessary sentinel node biopsies in patients with ductal cancer in situ
Not Applicable
Recruiting
- Conditions
- Ductal Cancer in Situ (DCIS)CancerBreast cancer
- Registration Number
- ISRCTN18430240
- Lead Sponsor
- ppsala University
- Brief Summary
2019 results in: https://doi.org/10.1002/bjs.11110
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 300
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber 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 Measures
Name Time Method 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