An observational study in Breast Cancer and MRI Imaging, sponsored by Amal Ahmed Helmy. Not yet recruiting. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Amal Ahmed Helmy · Observational
Breast cancer is the most common cancer in women worldwide [1]. The burden is heaviest in low- and middle-income countries, where late detection, limited screening access and scarce biopsy resources delay diagnosis [2,3]. Accessible, non-invasive imaging that can triage patients accurately is therefore needed. Digital mammography and digital breast tomosynthesis are the reference tools for detecting microcalcifications, which are often the earliest visible sign of ductal carcinoma in situ (DCIS) and can appear before any mass or architectural distortion [4].
Microcalcifications also carry prognostic information that influences surgical planning and management [5,6]. They arise through comedonecrosis and through osteomimicry, in which tumor cells acquire bone-forming features [6,7]. Dynamic contrast-enhanced (DCE) breast MRI is highly sensitive for invasive cancer [8]. However, calcifications and metallic biopsy markers have very short T2 relaxation times and appear as signal voids that cannot be separated from air or fibrosis. Marker artifacts can measure 2-6 times the marker diameter and may obscure adjacent tumor [9]. Full lesion characterization may therefore need several examinations, radiation, contrast and biopsy.
Zero echo time (ZTE) MRI samples signal at an echo time of about 0 ms with a three-dimensional radial acquisition. With gray-scale inversion it gives CT-like contrast without radiation or contrast agent and is established in musculoskeletal imaging [10]. Whether ZTE adds value to routine breast MRI is unknown.
Research question: In women referred for diagnostic or staging breast MRI, does adding ZTE to the routine protocol accurately detect calcifications and improve biopsy-marker visualization compared with mammography and histopathology?
12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's planned enrollment of 100 is below the median of 184 across 2,711 observational studies indexed under Breast Neoplasms.
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Adult women undergoing routine clinical breast MRI for suspected breast lesions, microcalcification evaluation, post-biopsy clip marker localization, or preoperative staging.
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Exclusion Criteria:
Patients undergoing clinical breast MRI will have a 3D Zero Echo Time (ZTE) pulse sequence added to the standard dynamic contrast-enhanced (DCE) breast MRI protocol. The ZTE sequence provides high tissue-to-bone/calcification contrast with minimal acoustic noise and ultra-short echo time. Images will be evaluated for diagnostic accuracy, lesion characterization, and visualization of breast calcifications or structural details compared to standard MRI sequences and/or mammography.
Diagnostic Accuracy, Marker Conspicuity, and Image Quality of ZTE Breast MRI
Primary Aims: To evaluate the diagnostic accuracy of adding 3D ZTE MRI to routine breast MRI for detecting microcalcifications, against mammography and, when available, histopathology; to assess biopsy-marker conspicuity and blooming artifact; to compare ZTE image quality and artifacts with routine sequences; and to determine whether ZTE fits the standard
Time frame: Baseline
Utility and Feasibility of ZTE Breast MRI
Secondary aims: to assess reader confidence and inter-reader agreement (κ \> 0.80), the correlation between ZTE-based density assessment and mammographic BI-RADS density, additional scan time and patient tolerance.
Time frame: Baseline
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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