OctavaPink for Women With Dense Breast After Negative Mammography

NCT ID: NCT02209389

Last Updated: 2014-08-19

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1750 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2017-08-31

Brief 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.

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.

Conditions

Breast Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Positive OctavaPink

Following a positive OctavaPink result, an MRI is performed and any additional testing (required by the MRI).

MRI

Intervention Type: DEVICE

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).

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.

MRI

Intervention Type: DEVICE

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).

Interventions

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).

Intervention Type: DEVICE

Other Intervention Names

Magnetic Resonance Imaging

Eligibility Criteria

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.

• Subjects with current biopsy/surgery proven breast cancer.

• 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.

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.

• Subjects with current mammography BIRADS assessment other than 1 or 2.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Eventus Diagnostics Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Edith Perez, Prof.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic, Jacksonville Florida USA

Locations

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

Countries

United States; Israel; Italy

Central Contacts

Galit Yahalom, PhD.

Role: CONTACT

galit@eventusdx.com

+97226738854

Sarah Cohen, CRA

Role: CONTACT

sarah@eventusdx.com

+97226738854

Facility Contacts

Benjamin Taggart, B.S.

Role: primary

benjamin.taggart@dcrc.us

248-716-7009

Strano, Prof.

Role: primary

strano@szmc.org.il

Sklair, Dr.

Role: primary

Miri.SklairLevy@sheba.health.gov.il

Tanir Allweis, Dr.

Role: primary

tanirallweis@gmail.com

Orit Golan, Dr.

Role: primary

oritgolan@gmail.com

Iacobelli, Dr.

Role: primary

daniela.iacobelli@alice.it

References

Yahalom G, Weiss D, Novikov I, Bevers TB, Radvanyi LG, Liu M, Piura B, Iacobelli S, Sandri MT, Cassano E, Allweis TM, Bitterman A, Engelman P, Vence LM, Rosenberg MM. An Antibody-based Blood Test Utilizing a Panel of Biomarkers as a New Method for Improved Breast Cancer Diagnosis. Biomark Cancer. 2013 Nov 19;5:71-80. doi: 10.4137/BIC.S13236. eCollection 2013.

Reference Type: BACKGROUND

PMID: 24324350 (View on PubMed)

Other Identifiers

OctavaPink for Dense Breast

Identifier Type: -

Identifier Source: org_study_id