Detection of early premalignant breast lesions by autofluorescence ductoscopy

Breast cancer remains the leading cause of mortality among women in the Western
world. For example, in the Netherlands, breast cancer is the most commonly
diagnosed neoplasm in women. Although survival has been improved, eventually
25% of the breast cancer patients will die of their disease. Best approach in
minimizing morbidity and mortality related to breast cancer, is by preventing
the development of breast cancer.
In women with the highest breast cancer risk, e.g. carriers of a BRCA mutation,
in order to prevent breast cancer surgical removing both breasts reduces the
incidence of breast cancer and improves survival, but is an invasive surgical
treatment and some of these women would have never developed breast cancer and
therefor receive overtreatment. However, conventional imaging misses about 40%
of the early staged breast cancer lesions. More sensitive screening and
non-invasive treatment methods of early precursor breast lesions would
therefore have a lot of benefits.
Ductoscopy is a minimally invasive micro-endoscopic approach for direct
visualization of intraductal leasions of the breast. Autofluorescence is a
noninvasive imaging technique added to ductoscopy that might help to identify
intraductal precursor lesions of breast cancer under direct vision.

Is ductoscopy with white light and autofluorescent light a useful method for
diagnosing precancerous breast lesions?

This is a prospective invasive observational phase II cohort study.

The study population will not have any benefit of participation. Since all
procedures will be performed under general anesthesia in the operating room
there will be no physical discomfort. Ductoscopy is a minimally invasive
procedure, known to have only minor complications, being nipple pain and duct
perforation. Since all patients are undergoing mastectomy they will not suffer
from any of the known complications of the ductoscopy procedure. Pathological
analysis of the breast will not be interfered since we will only use
intraductal saline infusion to fascilitate the ductoscopy. There will be no
risk of spread of tumor cells in the breast cancer group, since it is a
non-invasive method and all patients will receive a mastectomy directly
afterwards. The duration of anesthesia will be prolonged half an hour by the
ductoscopy. There will be no extra tests, visits, questionnaires or diaries.