OctavaPink for Women With Dense Breast After Negative Mammography

August 18, 2014 updated by: Eventus Diagnostics Ltd

OctavaPink® For Dense Breast After Negative Mammography

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This is a multicenter, prospective study containing 3 parts:

Part 1 consists of Part 1A (optimization/training) and Part 1B (evaluation/testing) as follows:

Part 1A will optimize the OctavaPink test for women with dense breast tissue, and will not affect the treatment of the participants. Part 1A is an internal part done by EventusDx and no statistical evaluation is needed.

Objectives: To optimize the OctavaPink test, with the target of ≥95% specificity and ≥70% sensitivity.

Part 1B will assess the properties of the OctavaPink test using cases and controls obtained via the same criteria as in Part 1A. The sensitivity and specificity of the OctavaPink test must be confirmed as sufficiently high in samples in which EventusDx is blind to case/control status before using the test to affect clinical management of patients.

Objectives:

(i) To obtain a sensitivity estimate ≥60% with 95% CI lower limit ≥50% in the whole group of cancer cases (DCIS, IDC and ILC); also to obtain a sensitivity estimate with the same properties in the subset of cases with invasive cancer (IDC and ILC).

(ii) To obtain a specificity estimate ≥90% in controls with 95% CI lower limit ≥85%.

Part 2 will examine the yield of cancer detection by MRI/biopsy among women who have a positive OctavaPink test result in the dense breast negative mammography population.

Objectives:

(i) To compare the yield of cancer detection via MRI/biopsy among women with a positive OctavaPink test versus a negative OctavaPink test result.

(ii) To estimate the proportion of patients who are positive for the test in the target population

Part 3 will assess sensitivity of OctavaPink test in an enriched population of women with dense breasts and negative mammography.

Objectives: To obtain an estimate of sensitivity in women with dense breast tissue and negative mammography that is broadly consistent with that found in the dense breast population (but not necessarily negative mammogram) in Parts 1A and 1B.

Study Type

Observational

Enrollment (Anticipated)

1750

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel
        • Shaarey Tzedek
      • Ramat Gan, Israel
        • Shiba
      • Rehovot, Israel
        • Kaplan Medical Center
      • Tel Aviv, Israel
        • Sourasky Medical Center
  • Italy
      • Rome, Italy
        • Fondazione Carlo ferri
  • United States
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Detroit Clinical Research Center
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

The study population for all parts of the protocol includes women above 30, who have had a mammography in the past 5-18 months, for which the result was negative (BIRADS assessment category 1 or 2), and on which they were defined as having dense breast tissue (BIRADS composition/density 3 or 4).

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Positive OctavaPink
Following a positive OctavaPink result, an MRI is performed and any additional testing (required by the MRI).
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).
Other Names:
  • Magnetic Resonance Imaging
Negative OctavaPink - control

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 recalled for an MRI and any additional testing (required by the MRI).

MRI won't be performed to all negative OctavaPink results. Only one negative control will be assigned to each OctavaPink positive result.
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).
Other Names:
  • Magnetic Resonance Imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Positive MRI as an approval for a positive OctavaPink test
Time Frame: Approximately two month following a positive Octava test
Approximately two month following a positive Octava test

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eventus Diagnostics Ltd

Investigators

  • Principal Investigator: Edith Perez, Prof., Mayo Clinic, Jacksonville Florida USA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Anticipated)

August 1, 2015

Study Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

July 29, 2014

First Submitted That Met QC Criteria

August 4, 2014

First Posted (Estimate)

August 5, 2014

Study Record Updates

Last Update Posted (Estimate)

August 19, 2014

Last Update Submitted That Met QC Criteria

August 18, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OctavaPink for Dense Breast

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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