Clinical trial · Interventional
Evaluation of the Diagnostic Performance of a Bra Prototype to Detect Breast Cancer
- 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)
Phi-Bra is a prospective and monocentric pilot study to assess the diagnostic capability of an innovative bra prototype to detect breast cancer, compared to the current standard of care: the mammography. The Phi-Bra prototype is designed with sensors measuring different parameters simultaneously such as impedance and temperature. The bra will be tested on patients without breast lump (American College of Radiology (ACR) 1 et 2 Birads classification) and with breast lump (ACR 4b, c ou ACR 5 Birads classification). The aim of this pilot study is to compare the results obtained by Phi-Bra to the ones obtained by mammography. The Phi-Bra study is classified as clinical investigation category 4.4 based on the European Union (EU) regulation (DM 2017/745).
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 Neoplasm Female | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Phi-Bra prototype measurements | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Patient without breast lump
- description
- No breast lump identified during mammography (ACR 1 et 2 Birads classification)
- interventionNames
- Device: Phi-Bra prototype measurements
- type
- EXPERIMENTAL
- label
- Patient with breast lump
- description
- Suspicious breast lump identified during mammography (ACR 4b, c ou ACR 5 Birads classification)
- interventionNames
- Device: Phi-Bra prototype measurements
Primary outcomes (1)
- measure
- Aria Under Receiver Operating Characteristic (ROC) Curve
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Age between 18 and 75. * No breast cancer surgery background * Bra size : S/M or M/L Specific criteria for the "no breast lump" cohort: \- Negative mammography result (ACR 1 a 2). Specific criteria for the "breast lump" cohort: \- Suspicious breast lump discovered during the mammography (ACR 4b ou c ou ACR 5) and for which there is an indication of microbiopsy. Exclusion Criteria: * Breast cancer background (surgery or radiotherapy) * Breast lump classified as ACR 3 ou ACR 4a during the mammography
References
Publications (0)
Data not yet available