Clinical trial · Observational
Clinical Evaluation of CEM-guided Biopsy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Contrast Enhanced Mammography-guided Biopsy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CEM-guided biopsy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Adult women with indication for a breast biopsy procedure after an abnormal CEM or MRI examination.
- description
- 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.
- interventionNames
- Device: CEM-guided biopsy
Primary outcomes (1)
- measure
- Image visibility of enhancing finding
- timeFrame
- immediately after each CEM-guided biopsy
- description
- 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.
Secondary outcomes (5)
- measure
- Pathology results on biopsy specimen
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Findings not accessible for stereotactic guidance biopsy * Are currently lactating * Have breast implants
References
Publications (11)
- BACKGROUNDSchrading 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
- BACKGROUNDWecsler 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
- BACKGROUNDMeissnitzer 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
- BACKGROUNDAbe 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
- BACKGROUNDPerlet 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
- BACKGROUNDSiegmann-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
- BACKGROUNDSantiago 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.