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NCT Number: NCT07354490

Accuracy of Sono-mammographic Features in Molecular Classification of Breast Cancer

This study aims to evaluate the role of mammographic and sonographic features as non-invasive imaging tools in predicting the molecular subtypes of breast cancer, in correlation with histopathological findings.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

About this study

Breast cancer is the most prevalent form of cancer among women. In the Middle East, it is the primary reason for cancer-related deaths among women

Breast cancer has been classified into various histopathological and molecular subtypes based on its hormone receptor status. Their biological behaviour and prognosis depend on these hormonal subtypes.

Based on gene expression patterns, breast cancer has been classified into five different molecular subtypes by the St. Gallen International Expert Consensus. They include:

  • Luminal A (LA).
  • Human epidermal growth factor receptor 2 (HER2) enriched.
  • Luminal B (LB) [LB HER2-, LB HER2+].
  • Basal-like (triple-negative). The detection of these hormone receptors requires immunohistochemistry (IHC), which is an invasive, expensive method and may not be available in all centres, especially in less developed countries

Hence, it is important to establish imaging signatures that can play an adjunct role in predicting these subtypes and assist in pre-treatment planning (4)

Mammography (MG) and Ultrasound (US) are routinely used during breast cancer screening, and are commonly used to identify and characterise breast lesions and guide biopsy. Unlike breast MRI, these two modalities are virtually always and everywhere available at the time of cancer diagnosis. In this work, the investigators thus investigate the feasibility of predicting molecular subtypes of breast cancer from the combination of Mammography and Ultrasound.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-The patients having BI-RADS IV, V, VI proven breast cancer.

Exclusion criteria

-Patients with post-neoadjuvant therapy and a prior history of breast cancer in the same breast with recurrence.

Treatment and study plan

Diagnostic test: Ultrasound and Mammogram

Other

Patients will receive digital bilateral mammography (craniocaudal and mediolateral oblique views) followed by high-resolution breast ultrasound using a linear transducer, performed by an experienced radiologist.

Primary outcomes

  1. Diagnostic performance of imaging features (Mammogram ,ultrasound ,and combined) for predicting molecular subtypes (Luminal A/B, HER2-enriched, TNBC)

    Time frame: from imaging to histopathological confirmation (up to 2 weeks)

    The investigators will use mammographic and songraphic features encompassing morphology, margins, posterior echo, blood flow grading, and the presence or absence of calcification ,predict molecular subtypes, then compare it to the hispathological results.

Secondary outcomes

  1. -AUC, sensitivity, specificity, accuracy, PPV/NPV for each subtype. -Agreement between imaging-based classification and reference standard (histopathology + IHC): -Cohen's kappa (overall and per subtype).

    Time frame: From imaging to histopathological and immunohistochemical confirmation (up to 2 weeks).

Study contacts

Contact information is provided by the study sponsor or research team.

Mai Abdelbaset Ahmed

CONTACT

[email protected]

+201094657457

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Imaging-Pathologic Correlation of Breast Cancer: Mammographic and Sonographic Features in Relation to Molecular Classification

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jan 21, 2026
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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