Contrast Enhanced Mammography-guided BiopsyNCT05250674
Clinical Evaluation of CEM-guided Biopsy
An observational study of Contrast Enhanced Mammography-guided Biopsy, run by Parc de Salut Mar at 1 site in Spain.
Trial summary
CEM-guided biopsy is an optional accessory of Senographe Pristina intended to provide accurate location of lesions in the breast in three dimensions, using information obtained from Contrast Enhanced Mammography (CEM) images. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contrast Enhanced Mammography-guided Biopsy
- What is being tested?
- CEM-guided biopsy
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 66 participants
- Where
- 1 siteSpain
- Study dates
- 8 Oct 2019to 6 Oct 2021
- Phase
- Observational
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult women presenting with clinical indication for a breast biopsy procedure after a positive abnormal CEM or MRI examination, and considered eligible for this procedure as per standard of care.
Who may be able to join
- Adult women presenting with clinical indication for a breast biopsy procedure after a positive abnormal CEM or MRI examination, and considered eligible for this procedure as per standard of care.
- Are able and willing to comply with study procedures
- Are able and willing to provide written informed consent to participate
Who cannot join
- Findings not accessible for stereotactic guidance biopsy
- Are currently lactating
- Have breast implants
Trial locations and contacts
1 site in 1 country.
About this study
CEM-guided biopsy is an optional accessory of Senographe Pristina intended to provide accurate location of lesions in the breast in three dimensions, using information obtained from Contrast Enhanced Mammography (CEM) images. This information provides guidance for a variety of minimally invasive or interventional procedures in the breast such as vacuum assisted biopsy, core biopsy, presurgical localization (e.g. hook wire), and fine needle aspirations (FNA). This device cannot be used for reasons other than its intended use.
This evaluation is being done to learn more about the CEM-guided biopsy. Clinical user and operational feedback is a central part of the development process for medical devices in which information from real clinical use is required to optimize the device prior to commercial release.
Read the detailed description
Pristina Serena CEM is an option to the standard Pristina Serena breast biopsy unit. It is designed to allow the accurate localization of lesions in the breast in three dimensions, using information obtained from Contrast Enhanced Mammography (CEM) images. It is intended to provide guidance for histological purposes such as core or vacuum-assisted biopsies, for pre-surgical localization procedures, or Fine Needle Aspiration (FNA) for cytopathology analysis.
The main purpose of this evaluation is to collect feedback to assess image readability and look-and feel, usability, workflow and user preference information from physicians and technologists who use CEM-guided biopsy to perform minimally invasive interventional breast procedures under clinical conditions. All feedbacks are collected by observations, interviews and surveys.
The evaluation population consists of adult women, presenting with clinical indication for a breast biopsy procedure after a positive abnormal CEM or MRI examination, and considered eligible for this procedure as per standard of care.
Eligible subjects undergo the clinically indicated breast biopsy procedure using the Pristina Serena CEM-guided biopsy. Region of interest location is determined by using stereotactic pairs of CEM images after injection of iodinated contrast media. All necessary equipment and instrumentation, medications, or other devices required to complete the subject's clinically indicated procedure shall be used and are not expected to be influenced by evaluation participation.
- Being tested
- CEM-guided biopsy
- Keywords
- Contrast Enhanced Mammography, breast cancer, interventional breast procedures
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CEM-guided biopsyDevice
The evaluation population consists of adult women, presenting with clinical indication for a breast biopsy procedure after a positive abnormal CEM or MRI examination (with no clear ultrasound or mammography correlation) and considered eligible for this procedure as per standard of care.
Eligible subjects undergo the clinically indicated breast biopsy procedure using the Pristina Serena Bright ® CEM-guided biopsy. Region of interest location is determined by using stereotactic pairs of CEM images after injection of iodinated contrast media. All necessary equipment and instrumentation, medications, or other devices required to complete the subject's clinically indicated procedure shall be used and are not expected to be influenced by evaluation participation.
| Study group | Role | What they receive |
|---|---|---|
| Adult women with indication for a breast biopsy procedure after an abnormal CEM or MRI examination. | Adult women presenting with clinical indication for a breast biopsy procedure after a positive abnormal CEM or MRI examination and no clear ultrasound or mammography correlation. Receives: Device: CEM-guided biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Image visibility of enhancing finding
To assess the visibility of an index enhancing finding at the point of the CEM-guided biopsy. The enhancement in the biopsy images will be compared to the enhancing lesion initially detected at the diagnostic CEM examination, that led to the prescription of the breast biopsy. It is a subjective and dichotomous measure: visible or not visible.
Measured: immediately after each CEM-guided biopsy
Secondary outcomes (5)
Pathology results on biopsy specimen
Pathology results are classified according to the National Health Service Breast Screening Program (NHSBSP) classification for breast biopsies in B1 (normal tissue), B2 (benign lesion), B3 (lesion of uncertain malignant potential), B4 (suspicious), B5 (malignant).
Measured: up to 3 weeks
Upgrade rate to malignancy of biopsied lesions that underwent surgical or percutaneous intervention
To evaluate the upgrade rate to malignancy of lesions that were further assessed with surgical or percutaneous intervention. The term "upgrade to malignancy" applies for lesions that were diagnosed as high-risk lesions at biopsy (B3), but with final pathology at excision changed to malignancy (in situ or invasive), as well as for in situ lesions at biopsy upstaged to invasive cancer at surgery.
Measured: an average of 3 months
Number of participants with CEM-guided biopsy minor complications.
To register the number of participants that underwent minor complications related to the CEM-guided procedure, such as presence of immediate hematoma in biopsy bed or experienced vasovagal reactions during or inmediately after the procedure. This information will be registered in three categories: hematoma, vasovagal reaction or no complications.
Measured: immediately after each CEM-guided biopsy
Biopsy needle approach
To register the needle entry to the breast in order to access the intended lesion during the biopsy procedure as it was through a vertical or horizontal approach. It is a dichotomous measure: vertical or horizontal.
Measured: immediately after each CEM-guided biopsy
Total time per procedure
To register the time spent during the biopsy procedure. The time will be considered since the intravenous contrast administration until the breast decompression, immediately after clip marker deployment. It is a numeric variable and will be measured in minutes and evaluated as a median interquartile range.
Measured: immediately after each CEM-guided biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start8 Oct 2019
- Primary completion27 Sep 2021
- Study completion6 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Contrast Enhanced Mammography-guided BiopsyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Collaborators
- General Electric
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05250674
- Sponsor's protocol ID
- 2019-8890
- Status last verified
- Nov 2021
- First submitted
- 2 Dec 2021
- Last updated
- 22 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Schrading S, Distelmaier M, Dirrichs T, Detering S, Brolund L, Strobel K, Kuhl CK. Digital breast tomosynthesis-guided vacuum-assisted breast biopsy: initial experiences and comparison with prone stereotactic vacuum-assisted biopsy. Radiology. 2015 Mar;274(3):654-62. doi: 10.1148/radiol.14141397. Epub 2014 Nov 11.
PubMed 25386875Wecsler J, Jeong YJ, Raghavendra AS, Mack WJ, Tripathy D, Yamashita MW, Sheth PA, Hovanessian Larsen L, Russell CA, MacDonald H, Sener SF, Lang JE. Factors associated with MRI detection of occult lesions in newly diagnosed breast cancers. J Surg Oncol. 2020 Mar;121(4):589-598. doi: 10.1002/jso.25855. Epub 2020 Jan 26.
PubMed 31984517Meissnitzer M, Dershaw DD, Lee CH, Morris EA. Targeted ultrasound of the breast in women with abnormal MRI findings for whom biopsy has been recommended. AJR Am J Roentgenol. 2009 Oct;193(4):1025-9. doi: 10.2214/AJR.09.2480.
PubMed 19770325Abe H, Schmidt RA, Shah RN, Shimauchi A, Kulkarni K, Sennett CA, Newstead GM. MR-directed ("Second-Look") ultrasound examination for breast lesions detected initially on MRI: MR and sonographic findings. AJR Am J Roentgenol. 2010 Feb;194(2):370-7. doi: 10.2214/AJR.09.2707.
PubMed 20093598Perlet C, Heywang-Kobrunner SH, Heinig A, Sittek H, Casselman J, Anderson I, Taourel P. Magnetic resonance-guided, vacuum-assisted breast biopsy: results from a European multicenter study of 538 lesions. Cancer. 2006 Mar 1;106(5):982-90. doi: 10.1002/cncr.21720.
PubMed 16456807Siegmann-Luz KC, Bahrs SD, Preibsch H, Hattermann V, Claussen CD. Management of breast lesions detectable only on MRI. Rofo. 2014 Jan;186(1):30-6. doi: 10.1055/s-0033-1335972. Epub 2013 Jul 29.
PubMed 23897532Santiago L, Candelaria RP, Huang ML. MR Imaging-Guided Breast Interventions: Indications, Key Principles, and Imaging-Pathology Correlation. Magn Reson Imaging Clin N Am. 2018 May;26(2):235-246. doi: 10.1016/j.mric.2017.12.002. Epub 2018 Feb 21.
PubMed 29622128Esserman LE, Cura MA, DaCosta D. Recognizing pitfalls in early and late migration of clip markers after imaging-guided directional vacuum-assisted biopsy. Radiographics. 2004 Jan-Feb;24(1):147-56. doi: 10.1148/rg.241035052.
PubMed 14730043Clauser P, Mann R, Athanasiou A, Prosch H, Pinker K, Dietzel M, Helbich TH, Fuchsjager M, Camps-Herrero J, Sardanelli F, Forrai G, Baltzer PAT. A survey by the European Society of Breast Imaging on the utilisation of breast MRI in clinical practice. Eur Radiol. 2018 May;28(5):1909-1918. doi: 10.1007/s00330-017-5121-4. Epub 2017 Nov 22.
PubMed 29168005Schrading S, Strobel K, Keulers A, Dirrichs T, Kuhl CK. Safety and Efficacy of Magnetic Resonance-Guided Vacuum-Assisted Large-Volume Breast Biopsy (MR-Guided VALB). Invest Radiol. 2017 Mar;52(3):186-193. doi: 10.1097/RLI.0000000000000331.
PubMed 27861232Neeter LMFH, Raat HPJF, Alcantara R, Robbe Q, Smidt ML, Wildberger JE, Lobbes MBI. Contrast-enhanced mammography: what the radiologist needs to know. BJR Open. 2021 Nov 24;3(1):20210034. doi: 10.1259/bjro.20210034. eCollection 2021.
PubMed 34877457
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of CEM-guided Biopsy
- ClinicalTrials.gov ID
- NCT05250674
- Acronym / sponsor ID
- 2019-8890
- Keywords
- Contrast Enhanced Mammography, breast cancer, interventional breast procedures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Collaborators
- General Electric
- Study start
- 8 Oct 2019 (actual)
- Primary completion
- 27 Sep 2021 (actual)
- Study completion
- 6 Oct 2021 (actual)
- First posted
- 22 Feb 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.
CEM-guided biopsy is an optional accessory of Senographe Pristina intended to provide accurate location of lesions in the breast in three dimensions, using information obtained from Contrast Enhanced Mammography (CEM) images. This information provides guidance for a variety of minimally invasive or interventional procedures in the breast such as vacuum assisted biopsy, core biopsy, presurgical localization (e.g. hook wire), and fine needle aspirations (FNA). This device cannot be used for reasons other than its intended use.
This evaluation is being done to learn more about the CEM-guided biopsy. Clinical user and operational feedback is a central part of the development process for medical devices in which information from real clinical use is required to optimize the device prior to commercial release.
Detailed description
Pristina Serena CEM is an option to the standard Pristina Serena breast biopsy unit. It is designed to allow the accurate localization of lesions in the breast in three dimensions, using information obtained from Contrast Enhanced Mammography (CEM) images. It is intended to provide guidance for histological purposes such as core or vacuum-assisted biopsies, for pre-surgical localization procedures, or Fine Needle Aspiration (FNA) for cytopathology analysis.
The main purpose of this evaluation is to collect feedback to assess image readability and look-and feel, usability, workflow and user preference information from physicians and technologists who use CEM-guided biopsy to perform minimally invasive interventional breast procedures under clinical conditions. All feedbacks are collected by observations, interviews and surveys.
The evaluation population consists of adult women, presenting with clinical indication for a breast biopsy procedure after a positive abnormal CEM or MRI examination, and considered eligible for this procedure as per standard of care.
Eligible subjects undergo the clinically indicated breast biopsy procedure using the Pristina Serena CEM-guided biopsy. Region of interest location is determined by using stereotactic pairs of CEM images after injection of iodinated contrast media. All necessary equipment and instrumentation, medications, or other devices required to complete the subject's clinically indicated procedure shall be used and are not expected to be influenced by evaluation participation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult women with indication for a breast biopsy procedure after an abnormal CEM or MRI examination. | – | Device: CEM-guided biopsyAdult women presenting with clinical indication for a breast biopsy procedure after a positive abnormal CEM or MRI examination and no clear ultrasound or mammography correlation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult women presenting with clinical indication for a breast biopsy procedure after a positive abnormal CEM or MRI examination, and considered eligible for this procedure as per standard of care.
Key inclusion criteria (3 listed)
- Adult women presenting with clinical indication for a breast biopsy procedure after a positive abnormal CEM or MRI examination, and considered eligible for this procedure as per standard of care.
- Are able and willing to comply with study procedures
- Are able and willing to provide written informed consent to participate
Key exclusion criteria (3 listed)
- Findings not accessible for stereotactic guidance biopsy
- Are currently lactating
- Have breast implants
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 |
|---|---|---|
| CEM-guided biopsyThe evaluation population consists of adult women, presenting with clinical indication for a breast biopsy procedure after a positive abnormal CEM or MRI examination (with no clear ultrasound or mammography correlation) and considered eligible for this procedure as per standard of care. Eligible subjects undergo the clinically indicated breast biopsy procedure using the Pristina Serena Bright ® CEM-guided biopsy. Region of interest location is determined by using stereotactic pairs of CEM images after injection of iodinated contrast media. All necessary equipment and instrumentation, medications, or other devices required to complete the subject's clinically indicated procedure shall be used and are not expected to be influenced by evaluation participation. | Device | Adult women with indication for a breast biopsy procedure after an abnormal CEM or MRI examination. |
Primary outcome
Image visibility of enhancing finding
Time frame: immediately after each CEM-guided biopsy
To assess the visibility of an index enhancing finding at the point of the CEM-guided biopsy. The enhancement in the biopsy images will be compared to the enhancing lesion initially detected at the diagnostic CEM examination, that led to the prescription of the breast biopsy. It is a subjective and dichotomous measure: visible or not visible.
5 secondary outcomes
Pathology results on biopsy specimen
Time frame: up to 3 weeks
Upgrade rate to malignancy of biopsied lesions that underwent surgical or percutaneous intervention
Time frame: an average of 3 months
Number of participants with CEM-guided biopsy minor complications.
Time frame: immediately after each CEM-guided biopsy
Biopsy needle approach
Time frame: immediately after each CEM-guided biopsy
Total time per procedure
Time frame: immediately after each CEM-guided biopsy
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 22 Feb 2022.
- Background: PubMed 25386875Schrading S, Distelmaier M, Dirrichs T, Detering S, Brolund L, Strobel K, Kuhl CK. Digital breast tomosynthesis-guided vacuum-assisted breast biopsy: initial experiences and comparison with prone stereotactic vacuum-assisted biopsy. Radiology. 2015 Mar;274(3):654-62. doi: 10.1148/radiol.14141397. Epub 2014 Nov 11.
- Background: PubMed 31984517Wecsler J, Jeong YJ, Raghavendra AS, Mack WJ, Tripathy D, Yamashita MW, Sheth PA, Hovanessian Larsen L, Russell CA, MacDonald H, Sener SF, Lang JE. Factors associated with MRI detection of occult lesions in newly diagnosed breast cancers. J Surg Oncol. 2020 Mar;121(4):589-598. doi: 10.1002/jso.25855. Epub 2020 Jan 26.
- Background: PubMed 19770325Meissnitzer M, Dershaw DD, Lee CH, Morris EA. Targeted ultrasound of the breast in women with abnormal MRI findings for whom biopsy has been recommended. AJR Am J Roentgenol. 2009 Oct;193(4):1025-9. doi: 10.2214/AJR.09.2480.
- Background: PubMed 20093598Abe H, Schmidt RA, Shah RN, Shimauchi A, Kulkarni K, Sennett CA, Newstead GM. MR-directed ("Second-Look") ultrasound examination for breast lesions detected initially on MRI: MR and sonographic findings. AJR Am J Roentgenol. 2010 Feb;194(2):370-7. doi: 10.2214/AJR.09.2707.
- Background: PubMed 16456807Perlet C, Heywang-Kobrunner SH, Heinig A, Sittek H, Casselman J, Anderson I, Taourel P. Magnetic resonance-guided, vacuum-assisted breast biopsy: results from a European multicenter study of 538 lesions. Cancer. 2006 Mar 1;106(5):982-90. doi: 10.1002/cncr.21720.
- Background: PubMed 23897532Siegmann-Luz KC, Bahrs SD, Preibsch H, Hattermann V, Claussen CD. Management of breast lesions detectable only on MRI. Rofo. 2014 Jan;186(1):30-6. doi: 10.1055/s-0033-1335972. Epub 2013 Jul 29.
- Background: PubMed 29622128Santiago L, Candelaria RP, Huang ML. MR Imaging-Guided Breast Interventions: Indications, Key Principles, and Imaging-Pathology Correlation. Magn Reson Imaging Clin N Am. 2018 May;26(2):235-246. doi: 10.1016/j.mric.2017.12.002. Epub 2018 Feb 21.
- Background: PubMed 14730043Esserman LE, Cura MA, DaCosta D. Recognizing pitfalls in early and late migration of clip markers after imaging-guided directional vacuum-assisted biopsy. Radiographics. 2004 Jan-Feb;24(1):147-56. doi: 10.1148/rg.241035052.
- Background: PubMed 29168005Clauser P, Mann R, Athanasiou A, Prosch H, Pinker K, Dietzel M, Helbich TH, Fuchsjager M, Camps-Herrero J, Sardanelli F, Forrai G, Baltzer PAT. A survey by the European Society of Breast Imaging on the utilisation of breast MRI in clinical practice. Eur Radiol. 2018 May;28(5):1909-1918. doi: 10.1007/s00330-017-5121-4. Epub 2017 Nov 22.
- Background: PubMed 27861232Schrading S, Strobel K, Keulers A, Dirrichs T, Kuhl CK. Safety and Efficacy of Magnetic Resonance-Guided Vacuum-Assisted Large-Volume Breast Biopsy (MR-Guided VALB). Invest Radiol. 2017 Mar;52(3):186-193. doi: 10.1097/RLI.0000000000000331.
- Background: PubMed 34877457Neeter LMFH, Raat HPJF, Alcantara R, Robbe Q, Smidt ML, Wildberger JE, Lobbes MBI. Contrast-enhanced mammography: what the radiologist needs to know. BJR Open. 2021 Nov 24;3(1):20210034. doi: 10.1259/bjro.20210034. eCollection 2021.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contrast Enhanced Mammography-guided Biopsy, run by Parc de Salut Mar at 1 site in Spain.
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 3 inclusion and 3 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 22 Feb 2022. 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 Spain. 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?
Image visibility of enhancing finding (time frame: immediately after each CEM-guided biopsy). 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 NCT05250674, which also lists 11 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 22 Feb 2022; AzTrials last refreshed its copy on 6 Nov 2026.