Breast Neoplasm FemalePhi-BraNCT05574816
Evaluation of the Diagnostic Performance of a Bra Prototype to Detect Breast Cancer
A study testing Phi-Bra prototype measurements in people with Breast Neoplasm Female, run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Neoplasm Female
- What is being tested?
- Phi-Bra prototype measurements
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesFrance
- Study dates
- 30 Mar 2023to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Breast cancer background (surgery or radiotherapy)
- Breast lump classified as ACR 3 ou ACR 4a during the mammography
Trial locations and contacts
2 sites in 1 country.
France2 sites
Service de Gynecologie-Obstetrique, Hopital de la Croix Rousse
Lyon, 69004
Service de Radiologie, Hôpital de la Croix-Rousse
Lyon, 69004
About this study
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.
Read more
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
- Breast Neoplasm Female
- Being tested
- Phi-Bra prototype measurements
- Keywords
- Breast cancer detection, impedance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phi-Bra prototype measurementsDevice
The bra prototype will be placed on the patient's breast. The patient will stay in a half-lying position during 15 min, the time duration of the measurements. Measurements will not be painful.
Measurements will only be realized one time during the first and unique visit of the patient.
| Study group | Role | What they receive |
|---|---|---|
| Patient without breast lump | Active comparator | No breast lump identified during mammography (ACR 1 et 2 Birads classification) Receives: Device: Phi-Bra prototype measurements |
| Patient with breast lump | Experimental | Suspicious breast lump identified during mammography (ACR 4b, c ou ACR 5 Birads classification) Receives: Device: Phi-Bra prototype measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aria Under Receiver Operating Characteristic (ROC) Curve
The diagnostic performance of Phi-Bra to assess breast lump will be assessed by evaluating the ROC Area Under Curve (AUC), the reference being mammography as gold standard.
Measured: The day of inclusion
Secondary outcomes (2)
impedance optimal threshold
Determination of the impedance optimal threshold to detect breast lump in term of specificity and sensitivity (in Ohms)
Measured: The day of inclusion
Correlation between lump volume and device impedance
Measured: The day of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start30 Mar 2023
- Primary completion1 Feb 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Neoplasm FemaleStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marion CORTET, MD, PhD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05574816
- Sponsor's protocol ID
- 69HCL21_1085
- Acronym
- Phi-Bra
- Status last verified
- Jun 2024
- First submitted
- 7 Oct 2022
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Diagnostic Performance of a Bra Prototype to Detect Breast Cancer
- ClinicalTrials.gov ID
- NCT05574816
- Acronym / sponsor ID
- Phi-Bra / 69HCL21_1085
- Conditions
- Breast Neoplasm Female
- Keywords
- Breast cancer detection, impedance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 30 Mar 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 12 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient without breast lump | Active comparator | Device: Phi-Bra prototype measurementsNo breast lump identified during mammography (ACR 1 et 2 Birads classification) |
| Patient with breast lump | Experimental | Device: Phi-Bra prototype measurementsSuspicious breast lump identified during mammography (ACR 4b, c ou ACR 5 Birads classification) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age between 18 and 75.
- No breast cancer surgery background
- Bra size : S/M or M/L
- Negative mammography result (ACR 1 a 2).
- Suspicious breast lump discovered during the mammography (ACR 4b ou c ou ACR 5) and for which there is an indication of microbiopsy.
Key exclusion criteria (2 listed)
- Breast cancer background (surgery or radiotherapy)
- Breast lump classified as ACR 3 ou ACR 4a during the mammography
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phi-Bra prototype measurementsThe bra prototype will be placed on the patient's breast. The patient will stay in a half-lying position during 15 min, the time duration of the measurements. Measurements will not be painful. Measurements will only be realized one time during the first and unique visit of the patient. | Device | Patient with breast lump, Patient without breast lump |
Primary outcome
Aria Under Receiver Operating Characteristic (ROC) Curve
Time frame: The day of inclusion
The diagnostic performance of Phi-Bra to assess breast lump will be assessed by evaluating the ROC Area Under Curve (AUC), the reference being mammography as gold standard.
2 secondary outcomes
impedance optimal threshold
Time frame: The day of inclusion
Correlation between lump volume and device impedance
Time frame: The day of inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marion CORTET, MD, PhD principal investigator
Hospices Civils de Lyon
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phi-Bra prototype measurements in people with Breast Neoplasm Female, run by Hospices Civils de Lyon at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aria Under Receiver Operating Characteristic (ROC) Curve (time frame: The day of inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2024.