Detection of early premalignant breast lesions by autofluorescence ductoscopy
Phase 2
Completed
- Conditions
- 10006291breast carcinomabreast cancer
- Registration Number
- NL-OMON40131
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
- Women >=18 age
- Indication for mastectomy by recently pathologically proven malignancy OR choosing preventive mastectomy because of highly increased risk of breast cancer development.
Exclusion Criteria
- Pregnant women
- Under 18 years of age
- Former radiotherapy of thorax or breast (on the site of the operated breast)
- Former surgery of the nipple or areola (on the site of the operated breast)
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>With this study the (technical) feasibility of autofluorescence ductoscopy will<br /><br>be studied. The number and characteristics of intraductal lesions found with<br /><br>the two different types of ductoscopy (white-light vs. autofluorescence) will<br /><br>be compared. The number and visual characteristics of lesions found (and<br /><br>marked) by ductoscopy will be compared to the number and characteristics of<br /><br>lesions found by pathological analysis of the mastectomy specimens. </p><br>
- Secondary Outcome Measures
Name Time Method <p>To investigate the correlation between the projected characteristics of a<br /><br>precursor lesion in white and autofluorescent light and its histological<br /><br>characteristics.<br /><br>*</p><br>