Clinical trial · Observational
Tactile Breast Imaging Sensor for Tumor Malignancy Characterization
NCT02603211CI-TRIAL-00039753completedResults postedClinicalTrials.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 aim of this study is to see how well a tactile imaging sensor will detect for breast masses compared to traditional mammography and/or ultrasound. This device may allow a simple, convenient method to screen for breast tumors. This data will be used to check the feasibility of using the device to detect breast tumors.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| tactile imaging sensor or system made in our laboratory | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Women with Breast Tumors
- description
- Women with breast tumors.
- interventionNames
- Device: tactile imaging sensor or system made in our laboratory
Primary outcomes (1)
- measure
- Size Error in Millimeters
- timeFrame
- 1 year
- description
- We obtain the image of the tumor and estimate its size. We compare this with the mammogram size data to compute the size error.
Secondary outcomes (1)
- measure
- Malignancy Estimation Using Risk Score
- timeFrame
- 1 year
- description
- The tumor risk score is calculated from the tumor size and deformation index. The scale will be from 0 to 5. With 0 being likely to be benign and 5 being likely to be malignant. We weigh the size 30% and deformation index 70% to come with the risk score. The tumor size is given in millimeters and deformation index is unitless. Deformation Index represents the hardness of the tumor. The amount at which the probe tip gets deformed by applying a force is called deformation index. Under the condition that the applied force, depth of the tumor and size of the tumor phantom are kept constant, the softer tumor makes the probe tip deform less than the stiffer tumor. Hence the deformation index for stiffer inclusion will be higher than the softer tumors.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Women who had mammogram and/or ultrasound birads (category IV or V) * Women ages between 30 and 80. * Women who have been scheduled for biopsy from the Temple breast surgery clinic * Women who have been scheduled for biopsy by Dr. Kathleen Reilly. * Women, who speak and understand English. Exclusion Criteria: * Women who do not meet the criteria requiring biopsy. * Women who have allergic reaction to silicone. * Women who cannot speak or understand English. * Women who are pregnant. * Women, younger than 30 years old, and older than 80 years old.
References
Publications (0)
Data not yet available
No reference posted for this study.