Clinical trial · Observational
OctavaPink for Women With Dense Breast After Negative Mammography
OctavaPink® For Dense Breast After Negative Mammography
NCT02209389CI-TRIAL-00015415unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Positive OctavaPink
- description
- Following a positive OctavaPink result, an MRI is performed and any additional testing (required by the MRI).
- interventionNames
- Device: MRI
- label
- Negative OctavaPink - control
- description
- 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.
- interventionNames
- Device: MRI
Primary outcomes (1)
- measure
- Positive MRI as an approval for a positive OctavaPink test
- timeFrame
- Approximately two month following a positive Octava test
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 79 Years
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDYahalom 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. PMID 24324350