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Detection of early premalignant breast lesions by autofluorescence ductoscopy

Detection of early premalignant breast lesions by autofluorescence ductoscopy - Autofluorescence ductoscopy

Status
Active, not recruiting
Phases
Phase 2
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON40131
Enrollment
30
Registered
2014-04-10
Start date
2014-10-14
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer

Interventions

None listed

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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)

Design outcomes

Primary

MeasureTime frame
With this study the (technical) feasibility of autofluorescence ductoscopy will be studied. The number and characteristics of intraductal lesions found with the two different types of ductoscopy (white-light vs. autofluorescence) will be compared. The number and visual characteristics of lesions found (and marked) by ductoscopy will be compared to the number and characteristics of lesions found by pathological analysis of the mastectomy specimens.

Secondary

MeasureTime frame
To investigate the correlation between the projected characteristics of a precursor lesion in white and autofluorescent light and its histological characteristics. *

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)