Clinical trial · Observational
Classification of Breast Masses Based on Visco-elastic Properties Using SAVE Method
NCT04841252CI-TRIAL-00107076SAVEcompletedClinicalTrials.gov clinicaltrialsProvenance
- 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 this research is to conduct a clinical study to evaluate the efficacy of a noninvasive and quantitative tool for classification/diagnosis of breast masses. The main objective of this proposal is to test the SAVE (Sub-Hertz Analysis of Visco-Elasticity) method on a patient population of sufficient size to determine the sensitivity and specificity for malignant-benign discrimination of breast masses.
Conditions
Conditions (1)
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 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alpinion clinical ultrasound machine | Device | — | UNRESOLVED |
| FDA approved GE LOGIQ E9 (LE9) ultrasound | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Determine the efficacy of the SAVE method by correlating its results with pathology in a pathology in a population of patients with suspicious breast masses.
- timeFrame
- Before biopsy or at least 2 weeks post biopsy
- description
- Assessed using a two-phase design. The first phase will be the development aspects to determine a candidate threshold for T1 that produces Optimal diagnostic accuracy as quantified by the largest diagnostic odds ratio. The second phase of the study will be to apply this candidate threshold to the validation sample enrolled as a part of the specific aim to ensure diagnostic utility. For both phases of the analysis, overall diagnostic accuracy will be quantified by the area under the receiver operating characteristics (ROC) curve.
- measure
- Determine the efficacy of SAVE method in classifying non-specific masses in a group of breast patients on the follow-up list.
- timeFrame
- Before biopsy or at least 2 weeks post biopsy
- description
- The threshold determined in Aim 1 will be applied to the patients in this sample to calculate the diagnostic performance
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Females in age range between 18 and up who have a breast lesion that may or may not be suspicious for breast cancer, and are referred for Radiological investigation. Exclusion Criteria: * No history of mastectomy or implants, or having any condition that does not allow proper use of our imaging devices. * Only include patients with masses detectable under ultrasound.
References
Publications (0)
Data not yet available
No reference posted for this study.