Clinical trial · Interventional
Assessing the Sensitivity of "SureTouch™" in Women Undergoing Diagnostic and Screening Mammography
Assessing the Sensitivity of "SureTouch™" in Identifying Clinically Significant Masses in Women Undergoing Diagnostic and Screening Mammography
NCT04397029CI-TRIAL-00059045terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The benefit of completing the study was not worth exposing subjects to the risk during COVID. Delaying the return visits would make it difficult to analyze the changes in data overtime.
Summary
Brief summary (as posted)
Prospective, case-control study being conducted to determine the sensitivity of the SureTouch device in detecting known masses at a pre-determined level of specificity.
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 |
|---|---|---|---|
| SureTouch | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Subjects without messes
- description
- Subjects who are believed to be free of masses.
- interventionNames
- Device: SureTouch
- type
- EXPERIMENTAL
- label
- Subjects with known masses
- description
- Subjects with known masses.
- interventionNames
- Device: SureTouch
Primary outcomes (1)
- measure
- Primary
- timeFrame
- 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: Arm 1: * Female Subject presenting for screening mammography * 30-80 years of age, inclusive * Able to provide written informed consent Arm 2: * Female Subject presenting for diagnostic appointment and/or biopsy * 30-80 years of age, inclusive * 1-3 masses per breast * Masses between 0.5 cm and 3.5 cm only Exclusion Criteria: * Individuals who are unable to comprehend or unwilling to sign an informed consent form * Women younger than 30 or older than 80 * Pregnant women * Women who have undergone bilateral mastectomies * Males * Prisoners * Masses which are larger than 3.5 cm or smaller than 0.5 cm in size * Individuals with more than 3 masses per breast will be excluded due to the complexity of these cases
References
Publications (14)
- BACKGROUNDCancer Stat Facts: Female Breast Cancer. Surveillance, Epidemiology, and End Results Program (SEER). https://seer.cancer.gov/statfacts/html/breast.html#skipnav. Accessed July 2, 2018.
- BACKGROUNDNational Center for Health Statistics (US). Health, United States, 2016: With Chartbook on Long-term Trends in Health. Hyattsville (MD): National Center for Health Statistics (US); 2017 May. Report No.: 2017-1232. Available from http://www.ncbi.nlm.nih.gov/books/NBK453378/ PMID 28910066
- BACKGROUNDChang JM, Park IA, Lee SH, Kim WH, Bae MS, Koo HR, Yi A, Kim SJ, Cho N, Moon WK. Stiffness of tumours measured by shear-wave elastography correlated with subtypes of breast cancer. Eur Radiol. 2013 Sep;23(9):2450-8. doi: 10.1007/s00330-013-2866-2. Epub 2013 May 15. PMID 23673574
- BACKGROUNDMichaelson, James & Satija, Sameer & Moore, Richard & Weber, Griffin & Halpern, Elkan & Garland, Andrew & Kopans, Daniel & Hughes, Kevin. (2003). Estimates of the Sizes at Which Breast Cancers Become Detectable on Mammographic and Clinical Grounds. Journal of Women's Imaging. 5. 10.1097/00130747-200302000-00002.
- BACKGROUNDEvans A, Whelehan P, Thomson K, McLean D, Brauer K, Purdie C, Jordan L, Baker L, Thompson A. Quantitative shear wave ultrasound elastography: initial experience in solid breast masses. Breast Cancer Res. 2010;12(6):R104. doi: 10.1186/bcr2787. Epub 2010 Dec 1. PMID 21122101
- BACKGROUNDSkovorda AR, Klishko AN, Gusakian DA, Maevskii EI, Ermilova VD, Oranskaia GA, Sarvazian AP. [Quantitative analysis of mechanical characteristics of pathologically altered soft biological tissues]. Biofizika. 1995 Nov-Dec;40(6):1335-40. Russian. PMID 8590726
- BACKGROUNDKrouskop TA, Wheeler TM, Kallel F, Garra BS, Hall T. Elastic moduli of breast and prostate tissues under compression. Ultrason Imaging. 1998 Oct;20(4):260-74. doi: 10.1177/016173469802000403. PMID 10197347