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A study comparing two ultrasound techniques for diagnosing suspicious breast lumps in women.

Comparison of Diagnostic Accuracy Between Superb Microvascular Imaging & Sonomammography in Female Patients with BI-RADS 4 Breast Lumps - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/05/111144
Enrollment
246
Registered
2026-05-26
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

Interventions

Intervention1: Superb Microvascular Imaging (SMI): Patients with BI-RADS (Breast Imaging-Reporting and Data System) 4 breast lumps will undergo Superb Microvascular Imaging (SMI). Control Intervention

Sponsors

Aditya Sharma
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All females aged 18 years or older with newly diagnosed single BI-RADS 4 breast lumps. Patient who consents to inclusion in the study.

Exclusion criteria

Exclusion criteria: Pregnant patients. Lactating females.

Design outcomes

Primary

MeasureTime frame
Evaluate and compare the diagnostic accuracy of Superb Microvascular Imaging (SMI) and sonomammography in females with BI-RADS 4 breast lesions, using histopathological examination (HPE) as the reference standard, by assessing sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).Timepoint: Baseline: at the time of radiological assessment (sonomammography and SMI) and subsequent histopathological examination.—

Secondary

MeasureTime frame
Correlate the radiological features of superb microvascular imaging (SMI) with molecular subtype & correlate the radiological features of superb microvascular imaging (SMI) with Ki-67 proliferation index. Timepoint: Baseline & during final histopathological/immunohistochemical assessment after biopsy.—

Countries

India

Contacts

Public ContactFarhanul Huda

All India Institute of Medical Sciences, Rishikesh, Uttrakhand, India

farhanul1973huda@gmail.com09838376545

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026