Clinical Evaluation of CEM-guided Biopsy

NCT05250674 | Completed FDA Device

• 1 other identifier: 2019-8890
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Contrast Enhanced Mammography-guided Biopsy

Keywords

Contrast Enhanced Mammography; breast cancer; interventional breast procedures

Outcome Measures

Primary Outcomes (1)

• 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.

  immediately after each CEM-guided biopsy

Secondary Outcomes (5)

• Pathology results on biopsy specimen

  up to 3 weeks

• Upgrade rate to malignancy of biopsied lesions that underwent surgical or percutaneous intervention

  an average of 3 months

• Number of participants with CEM-guided biopsy minor complications.

  immediately after each CEM-guided biopsy

• Biopsy needle approach

  immediately after each CEM-guided biopsy

• Total time per procedure

  immediately after each CEM-guided biopsy

Study Arms (1)

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.

Device: CEM-guided biopsy

Interventions

CEM-guided biopsy DEVICE

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.

Adult women with indication for a breast biopsy procedure after an abnormal CEM or MRI examination.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• Findings not accessible for stereotactic guidance biopsy
• Are currently lactating
• Have breast implants

Sponsors & Collaborators

• Parc de Salut Mar: lead
• General Electric: collaborator

Study Sites (1)

Hospital del Mar - Parc de Salut Mar

Barcelona, Catalonia, 08003, Spain

Location

Related Publications (11)

• 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.

  PMID: 25386875 BACKGROUND

• Wecsler 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.

  PMID: 31984517 BACKGROUND

• Meissnitzer 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.

  PMID: 19770325 BACKGROUND

• Abe 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.

  PMID: 20093598 BACKGROUND

• Perlet 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.

  PMID: 16456807 BACKGROUND

• Siegmann-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.

  PMID: 23897532 BACKGROUND

• Santiago 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.

  PMID: 29622128 BACKGROUND

• Esserman 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.

  PMID: 14730043 BACKGROUND

• Clauser 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.

  PMID: 29168005 BACKGROUND

• Schrading 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.

  PMID: 27861232 BACKGROUND

• Neeter 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.

  PMID: 34877457 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: February 22, 2022
• Study Start: October 8, 2019
• Primary Completion: September 27, 2021
• Study Completion: October 6, 2021
• Last Updated: February 22, 2022

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)