Clinical validation of the optical mammography system

Clinical validation of the optical mammography system - MONA LISA - 1

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON30324

Enrollment

Registered

2006-07-18

Start date

2006-07-20

Completion date

Unknown

Last updated

2024-06-18

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

Conditions

breast cancer breast neoplasms

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: BIRADS 2-5 on X-ray mammography Patients should have both breasts Age > 18 years

Exclusion criteria

Exclusion criteria: recent breast biopsy/fine needle aspiration

Design outcomes

Primary

Measure	Time frame
Number and size of lesions and location within the breast will be recorded. The characteristics concerning contrast intensity and direction (i.e. higher or lower signal compared to background), and homogeneity will be scored for each lesion. The nature of the lesions (malignant/benign) will be determined by MR-mammography, and, if necessary, pathology report (reference standard). The safety of the PMS DOT system will also be assessed.	—

Measure

Time frame

Number and size of lesions and location within the breast will be recorded. The characteristics concerning contrast intensity and direction (i.e. higher or lower signal compared to background), and homogeneity will be scored for each lesion. The nature of the lesions (malignant/benign) will be determined by MR-mammography, and, if necessary, pathology report (reference standard). The safety of the PMS DOT system will also be assessed.

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Countries

Netherlands

Outcome results