First phase for high-resolution imaging of breast cancer lumps for 3D identification and quantification of resection margins
- Conditions
- Patients with breast cancer, IDC (n=3) and DCIS (n=3) scheduled for a lumpectomy.Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-002616-16-NL
- Lead Sponsor
- KI-AV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria
-Woman
-Age > 58
-Histological proven breast cancer DCIS or IDC, cT1c cNx
-Scheduled for breast tumour lumpectomy
-IDC: Distance nipple to tumour marker (I125-seed) >5cm
-Patiënten geven schriftelijk ‘informed consent’
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 6
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6
Exclusion Criteria
-A radioguided occult lesion localisation (ROLL) using Tc-99m
-Administration of other Tc-99m pharmaceuticals 48 hours prior to surgery (with the exception of Tc-99m for the SN procedure in case of IDC)
-Neo-adjuvant chemotherapy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method