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OctavaPink for Women With Dense Breast After Negative Mammography

NCT02209389 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1750

Last updated 2014-08-19

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

MRI

For any sample that is identified with a positive OctavaPink result, a negative sample from the same center, as close in time as possible, and of the same age decade, will be identified and will be recalled for an MRI and any additional testing if requested by doctor's (according to MRI's results).

Sponsors & Collaborators

  • Eventus Diagnostics Ltd

    lead INDUSTRY

Principal Investigators

  • Edith Perez, Prof. · Mayo Clinic, Jacksonville Florida USA

Eligibility

Min Age
30 Years
Max Age
79 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2015-08-31
Completion
2017-08-31

Countries

  • United States
  • Israel
  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02209389 on ClinicalTrials.gov