OctavaPink for Women With Dense Breast After Negative Mammography

Status unconfirmed

Conditions studied: Breast Cancer

In brief

The OctavaPink test is indicated as an adjunct to mammography for breast cancer screening in asymptomatic women for whom screening or diagnostic mammography findings are normal or benign (BIRADS assessment category 1 or 2) and breast tissue is dense (BIRADS composition/density 3 or 4). The device is intended to increase breast cancer detection in the described patient population. Based upon the result of OctavaPink, the patient will be further evaluated by their physician.

Key facts

Study ID

NCT02209389

Run by

Eventus Diagnostics Ltd

People needed

1750

Starts

2014-08-01

Expected to finish

2017-08-01

Last updated by the study team

2014-08-19

Who can join

Age: 30 and older, up to 79. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Subjects with dense breast tissue according to ACR criteria, (BIRADS composition/density 3 or 4), or with specific area of high density behind the nipple.
• Subject with current mammography BIRADS assessment category other than 3.
• Signed inform consent form.
• Additional inclusion criteria for Part 1A and Part 1B cases and Part 3 cases
• Subjects with current biopsy/surgery proven breast cancer.
• Additional inclusion criteria for Part 1A controls, Part 1B controls • Subjects with current negative mammography (BIRADS assessment category 1 or 2).
• Additional inclusion criteria for Part 2
• Subjects with current negative mammography (BIRADS assessment category 1 or 2). All will perform an additional 1 year (12-18 months) up mammography to verify negative results.
• Additional inclusion criteria for Part 3 • Enriched patient population - Subjects with current/recent (less than 12 months) negative mammography (BIRADS assessment category 1 or 2). Mammography evaluation can be performed after recruiting.

You may not qualify if…

• Previous or concurrent malignancies of any type except for basal cell carcinoma of the skin, squamous-cell carcinoma of the skin or cervical carcinoma in situ.
• Previous or current ADH, ALH, LCIS.
• Autoimmune disorders diagnosed subjects.
• Hematological malignancies.
• Subjects under active chemotherapy treatment or chemotherapy in the past 6 months.
• Steroid treatment in the past 3 months.
• Subject undergoing immunosuppressive treatments.
• Subject with current mammography BIRADS assessment category of 3.
• Pregnancy at time of recruitment.
• Doctor medical judgment that prohibits participation in the study.
• Participating in a parallel clinical study that involves drug treatment, or may influence the course of this clinical trial.
• Additional exclusion criteria for Part 3
• Subjects with current mammography BIRADS assessment other than 1 or 2.

Where it is running

• Detroit Clinical Research Center — Detroit, Michigan, United States
• MD Anderson cancer center — Houston, Texas, United States
• Shaarey Tzedek — Jerusalem, Israel
• Shiba — Ramat Gan, Israel
• Kaplan medical center — Rehovot, Israel
• Sourasky medical center — Tel Aviv, Israel
• Fondazione Carlo ferri — Rome, Italy

Full record on ClinicalTrials.gov

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