Identification and Semi-Quantification of Ki-67 Protein Expression Status

Applied Spectral Imaging

Status: Completed

Conditions: Breast Cancer

Treatments: Procedure: Women with Breast Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT02654457

ASI-Ki-67-IHC

Details and patient eligibility

About

The purpose of the study is the identification and semi-quantification of Ki-67 protein expression level in breast cancer tissues by the GenASIs GoPth system as compared to manual reading of the same slides.

The imaging system is intended for diagnostic use as an aid to the pathologist in the detection, counting and classifying ER/PR IHC stained samples

Full description

The anti Ki-67 is a semi-quantitative immunohistochemical (IHC) assay to identify the Ki-67 protein expressions in formalin-fixed, paraffin-embedded human breast cancer tissue specimens. Results from the Ki-67 test is indicated as an aid in the assessment of the protein status of breast cancer patients. While the p53 kit provides the antibody that offer direct visualization and semi-quantification of the protein expression through a brightfield microscope, the GenASIs GoPath system is designed to complement the routine workflow of the pathologist in the analysis and review of immunohistochemically stained histologic slides.

Enrollment: 3 patients

Sex: Female

Ages: 21 to 89 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Slides with nuclear borders of tumor nuclei that is distinguishable, and having good integrity.

Exclusion criteria

• Slides that have lots of background that interfere with the analysis

Trial design

3 participants in 3 patient groups

Women with Breast Cancer #1

Description:

IVD Study

Treatment:

Procedure: Women with Breast Cancer

Women with Breast Cancer #2

Description:

IVD Study

Treatment:

Procedure: Women with Breast Cancer

Women with Breast Cancer #3

Description:

IVD Study

Treatment:

Procedure: Women with Breast Cancer