Malignant Breast TumoursNCT01531036
3D Breast Ultrasound Elastography in Patients Under Neoadjuvant Chemotherapy
A study testing 3D Ultrasound elastography by means of shear wave propagation into breast tissue in people with Malignant Breast Tumours, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
Breast Ultrasound Elastography is a complementary technique permitting a better characterization of breast lesions. 3D breast ultrasound elastography is a novel technique permitting a volumetric calculation of lesion stiffness. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Malignant Breast Tumours
- What is being tested?
- 3D Ultrasound elastography by means of shear wave propagation into breast tissue
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2010to Nov 2012
- 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
- Patients having already undergone a breast MRI
- Patients presenting with breast lesions measuring between20-50mm in ultrasound
Who cannot join
- Multifocal lesions
- History of breast cancer
- Breast implants
- Inflammatory breast disease
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Imagerie 3D d'élasticité du Sein Par échographie Ultrarapide au Cours d'un Traitement Par chimiothérapie néoadjuvante.
Breast Ultrasound Elastography is a complementary technique permitting a better characterization of breast lesions. 3D breast ultrasound elastography is a novel technique permitting a volumetric calculation of lesion stiffness. This could be particularly useful in patients with large breast tumors under pre-operative chemotherapy
Read the detailed description
3D breast ultrasound elastography provides volumetric lesion stiffness details in real time. 3D acquisition is compared to breast MRI in order to evaluate volume measurements calculated in ultrasound. Lesion elasticity is calculated in 3 planes with immediate reconstruction. The purpose of this prospective study is to evaluate the feasibility of this technique and compare the results to those of Breast MRI. For women receiving preoperative chemotherapy, this technique will be evaluated with regard to tumour shrinkage and lesion elasticity modifications under treatment.
- Conditions
- Malignant Breast Tumours
- Being tested
- 3D Ultrasound elastography by means of shear wave propagation into breast tissue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D Ultrasound elastography by means of shear wave propagation into breast tissueDevice
Also called Aixplorer Supersonic Imagine
Aixplorer Supersonic Imagine Ultrasound System with 3D probe for real-time elastography
| Study group | Role | What they receive |
|---|---|---|
| shear wave imaging | Experimental | Single arm study evaluating breast 3D elastography by means of shear wave propagation into breast tissue. Receives: Device: 3D Ultrasound elastography by means of shear wave propagation into breast tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
3D volumetric elasticity measurements
An utrafast shear wave imaging 3-plane acquisition provides several frames of breast lesion elasticity, that are reconstructed by means of a dedicated software thus permitting the direct volumetric elasticity measurements in kPa
Measured: 10min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2012 (estimated)
- Study startDec 2010
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Malignant Breast TumoursStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Alexandra Athanasiou, MD, Principal investigator, Curie Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01531036
- Sponsor's protocol ID
- C10-02
- Other IDs
- 2010-A00663-36
- Status last verified
- Feb 2016
- First submitted
- 8 Feb 2012
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Athanasiou A, Tardivon A, Tanter M, Sigal-Zafrani B, Bercoff J, Deffieux T, Gennisson JL, Fink M, Neuenschwander S. Breast lesions: quantitative elastography with supersonic shear imaging--preliminary results. Radiology. 2010 Jul;256(1):297-303. doi: 10.1148/radiol.10090385. Epub 2010 May 26.
PubMed 20505064Athanasiou A, Latorre-Ossa H, Criton A, Tardivon A, Gennisson JL, Tanter M. Feasibility of Imaging and Treatment Monitoring of Breast Lesions with Three-Dimensional Shear Wave Elastography. Ultraschall Med. 2017 Jan;38(1):51-59. doi: 10.1055/s-0034-1398980. Epub 2015 Mar 5.
PubMed 25741668
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imagerie 3D d'élasticité du Sein Par échographie Ultrarapide au Cours d'un Traitement Par chimiothérapie néoadjuvante.
- ClinicalTrials.gov ID
- NCT01531036
- Acronym / sponsor ID
- C10-02
- Conditions
- Malignant Breast Tumours
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- Dec 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 10 Feb 2012 (estimated)
- 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.
Breast Ultrasound Elastography is a complementary technique permitting a better characterization of breast lesions. 3D breast ultrasound elastography is a novel technique permitting a volumetric calculation of lesion stiffness. This could be particularly useful in patients with large breast tumors under pre-operative chemotherapy
Detailed description
3D breast ultrasound elastography provides volumetric lesion stiffness details in real time. 3D acquisition is compared to breast MRI in order to evaluate volume measurements calculated in ultrasound. Lesion elasticity is calculated in 3 planes with immediate reconstruction. The purpose of this prospective study is to evaluate the feasibility of this technique and compare the results to those of Breast MRI. For women receiving preoperative chemotherapy, this technique will be evaluated with regard to tumour shrinkage and lesion elasticity modifications under treatment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| shear wave imaging | Experimental | Device: 3D Ultrasound elastography by means of shear wave propagation into breast tissueSingle arm study evaluating breast 3D elastography by means of shear wave propagation into breast tissue. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients having already undergone a breast MRI
- Patients presenting with breast lesions measuring between20-50mm in ultrasound
Key exclusion criteria (5 listed)
- Multifocal lesions
- History of breast cancer
- Breast implants
- Inflammatory breast disease
- Pregnancy
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 |
|---|---|---|
| 3D Ultrasound elastography by means of shear wave propagation into breast tissueAlso: Aixplorer Supersonic ImagineAixplorer Supersonic Imagine Ultrasound System with 3D probe for real-time elastography | Device | shear wave imaging |
Primary outcome
3D volumetric elasticity measurements
Time frame: 10min
An utrafast shear wave imaging 3-plane acquisition provides several frames of breast lesion elasticity, that are reconstructed by means of a dedicated software thus permitting the direct volumetric elasticity measurements in kPa
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 27 Aug 2025.
- Background: PubMed 20505064Athanasiou A, Tardivon A, Tanter M, Sigal-Zafrani B, Bercoff J, Deffieux T, Gennisson JL, Fink M, Neuenschwander S. Breast lesions: quantitative elastography with supersonic shear imaging--preliminary results. Radiology. 2010 Jul;256(1):297-303. doi: 10.1148/radiol.10090385. Epub 2010 May 26.
- Results publication: PubMed 25741668Athanasiou A, Latorre-Ossa H, Criton A, Tardivon A, Gennisson JL, Tanter M. Feasibility of Imaging and Treatment Monitoring of Breast Lesions with Three-Dimensional Shear Wave Elastography. Ultraschall Med. 2017 Jan;38(1):51-59. doi: 10.1055/s-0034-1398980. Epub 2015 Mar 5.
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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.
Alexandra Athanasiou, MD principal investigator
Curie Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D Ultrasound elastography by means of shear wave propagation into breast tissue in people with Malignant Breast Tumours, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site 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 2 inclusion and 5 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 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
3D volumetric elasticity measurements (time frame: 10min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01531036, which also lists 2 linked publications.
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 27 Aug 2025.