Clinical trial · Observational
Three-Dimensional Ultrasound Imaging and Spectroscopy for Characterizing Breast Masses
Investigation of Three-Dimensional Ultrasound Imaging and Spectroscopy for Characterizing Breast Masses
- 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)
The purpose of the study is to test the hypothesis that quantitative ultrasound techniques including spectroscopy may be used as a non-invasive biomarker for characterization of suspected breast cancers. The main goal is to select and identify an optimal set of quantitative ultrasound parameters that can be used, non-invasively, to characterize suspected breast cancers, as identified based on the histopathology reports on core biopsy specimens, surgery reports, or radiology reports. Primary endpoint will correlate quantitative ultrasound parameters to the histopathological properties, as determined from pathology reports on core biopsy specimens, surgery reports, or radiology reports. The secondary endpoint in this study will include correlating the results of ultrasound-based breast cancer characterization with 2 and 5-years clinical outcomes.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Masses | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ultrasound Imaging 3D and Spectroscopy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patient with suspected breast cancer
- description
- Patients with suspected breast cancer will be recruited and scanned for this study. The results of ultrasound data analysis will be compared and correlated to the histopathology reports on routine core biopsy specimens, surgery reports, or radiology reports.
- interventionNames
- Device: Ultrasound Imaging 3D and Spectroscopy
Primary outcomes (1)
- measure
- Correlation of quantitative ultrasound parameters to the histopathological properties of suspected breast cancer tissues.
- timeFrame
- Up to 2 years
- description
- As a primary endpoint, correlate changes in ultrasound backscatter parameters obtained using spectroscopic techniques, in conjunction with textural analysis on generated parametric images, to the histopathological characteristics from pathology reports on core biopsy specimens, surgery reports, or radiology reports.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. Women or men with suspected breast cancer 2. Patients should have the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: 1. Patients who have had chemotherapy, radiotherapy, or major surgery within 4 weeks prior to registering in the study or those who have not recovered from adverse events due to agents administered more than 4 weeks prior to registration. 2. Receiving any other investigational agents. 3. Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study.
References
Publications (0)
Data not yet available