Portable device for detecting breast cancer
Smart Bra for Diagnosing Breast Cancer: Pilot Study - CBRA
NA · Hopital Nord Franche-Comte · NCT05294016
This study is testing a new portable device that helps find breast cancer early by checking for changes in breast tissue in a simple and non-invasive way.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Hopital Nord Franche-Comte (other) |
| Locations | 2 sites (Strasbourg and 1 other locations) |
| Trial ID | NCT05294016 on ClinicalTrials.gov |
What this trial studies
This project evaluates a connected medical device designed to detect breast abnormalities for screening breast cancer. The device, known as BRA CONNECT, aims to provide a non-invasive and efficient method for early detection of breast cancer. By utilizing advanced technology, the study seeks to improve the accuracy and accessibility of breast cancer screening. Participants will be monitored for the device's effectiveness in identifying potential cancerous changes in breast tissue.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with non-specific invasive carcinoma and having a breast size compatible with the study bra.
Not a fit: Patients with a history of breast cancer, inflammatory breast cancer, or those who have undergone certain breast surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could significantly enhance early detection of breast cancer, leading to better patient outcomes.
How similar studies have performed: While the approach of using a connected device for breast cancer detection is innovative, similar studies have shown promise in enhancing screening methods.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Non-specific invasive carcinoma diagnosed by biopsy * X-ray images available * Tumor larger than 1 cm assessed radiologically and/or by ultrasound and/or clinically * Patient with a breast size compatible with the study bra size Exclusion Criteria: * Contralateral breast cancer * Inflammatory breast cancer * History of cosmetic or plastic surgery (mastopexy, prosthesis, lipomodelling) * History of breast cancer or mastectomy * Presence of dermatological pathology or breast skin ulceration * Hematoma post biopsy * History of thoraco-abdominal radiotherapy * Known allergy to one of the materials of the device * Fever (body temperature \> 37.8°C) * Pacemaker port
Where this trial is running
Strasbourg and 1 other locations
- ICANS (Institut de Cancérologie de Strasbourg) — Strasbourg, France (NOT_YET_RECRUITING)
- Hôpital Nord Franche-Comté — Trevenans, France (RECRUITING)
Study contacts
- Study coordinator: Elodie Bouvier
- Email: elodie.bouvier@hnfc.fr
- Phone: 384983570
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer, Medical Device