Breast CancerNCT07882147
Diagnostic Accuracy and Utility of ZTE Added to Routine MRI
An observational study of Breast Cancer and MRI Imaging, run by Amal Ahmed Helmy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer, MRI Imaging
- What is being tested?
- MRI
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Jul 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Adult women undergoing routine clinical breast MRI for suspected breast lesions, microcalcification evaluation, post-biopsy clip marker localization, or preoperative staging.
Who may be able to join
- Female patients
- Referred for diagnostic or staging breast MRI
- Mammogram available within the previous 6 months, or a biopsy marker in place.
- Able to provide informed consent and tolerate MRI positioning.
Who cannot join
- - MRI contraindications (e.g., pacemaker or other MRI-unsafe implant, severe claustrophobia).
- Pregnancy or lactation.
- Contraindication to gadolinium.
- Prior mastectomy or breast radiation.
- Severe motion artifact
About this study
Official title: Diagnostic Accuracy and Utility of Adding Zero Echo Time (ZTE) MRI to Routine Breast Imaging
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.
Read more
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?
- Conditions
- Breast Cancer, MRI Imaging
- Being tested
- MRI
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Secondary outcomes (1)
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amal Ahmed Helmy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amal Ahmed Helmy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07882147
- Sponsor's protocol ID
- ZTE MRI value
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy and Utility of Adding Zero Echo Time (ZTE) MRI to Routine Breast Imaging
- ClinicalTrials.gov ID
- NCT07882147
- Acronym / sponsor ID
- ZTE MRI value
- Conditions
- Breast Cancer, MRI Imaging
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Amal Ahmed HelmyUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 20 Oct 2026 (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.
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?
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult women undergoing routine clinical breast MRI for suspected breast lesions, microcalcification evaluation, post-biopsy clip marker localization, or preoperative staging.
Key inclusion criteria (4 listed)
- Female patients
- Referred for diagnostic or staging breast MRI
- Mammogram available within the previous 6 months, or a biopsy marker in place.
- Able to provide informed consent and tolerate MRI positioning.
Key exclusion criteria (5 listed)
- - MRI contraindications (e.g., pacemaker or other MRI-unsafe implant, severe claustrophobia).
- Pregnancy or lactation.
- Contraindication to gadolinium.
- Prior mastectomy or breast radiation.
- Severe motion artifact
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 |
|---|---|---|
| MRIPatients 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. | Device | – |
Primary outcome
Diagnostic Accuracy, Marker Conspicuity, and Image Quality of ZTE Breast MRI
Time frame: Baseline
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
1 secondary outcome
Utility and Feasibility of ZTE Breast MRI
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and MRI Imaging, run by Amal Ahmed Helmy.
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 4 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: opening soon, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Diagnostic Accuracy, Marker Conspicuity, and Image Quality of ZTE Breast MRI (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Oct 2026.