Assessing the Sensitivity of "SureTouch™" in Women Undergoing Diagnostic and Screening Mammography

Breast Cancer Clinical Trial

Official title:

Assessing the Sensitivity of "SureTouch™" in Identifying Clinically Significant Masses in Women Undergoing Diagnostic and Screening Mammography

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04397029
• Other study ID #: GW10029
• Status: Terminated
• Phase: N/A
• Start date: January 4, 2019
• Est. completion date: February 10, 2021

Study information

• Verified date: May 2020
• Source: George Washington University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

This is a single-center, 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.

Results of the mammography will be compared to the SureTouch examination results.

Subjects will have between 1 and 3 research visits and 3 follow-up surveys, up to two years from the initial visit. The number of visits will be based upon comparison of the SureTouch examination to conventional breast screening techniques (mammogram and ultrasound).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 213
• Est. completion date: February 10, 2021
• Est. primary completion date: February 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Hypersensitivity

Intervention

Device:
• SureTouch
The first group will consist of 70 women who are believed to be free of masses, recruited during a screening mammography appointment. The second group will include 125 women presenting for diagnostic mammography and/or biopsy appointment with known masses identified on mammogram, ultrasound or both. Both groups will receive breast cancer screening with mammography and SureTouch.

Locations

Country	Name	City	State
United States	George Washington University - Medical Faculty Associates	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
George Washington University	Sure, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (14)

Cancer 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.

Chang 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. — View Citation

Evans 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. — View Citation

Heshmatzadeh Behzadi A, Farooq Z, Newhouse JH, Prince MR. MRI and CT contrast media extravasation: A systematic review. Medicine (Baltimore). 2018 Mar;97(9):e0055. doi: 10.1097/MD.0000000000010055. Review. — View Citation

Hunt CH, Hartman RP, Hesley GK. Frequency and severity of adverse effects of iodinated and gadolinium contrast materials: retrospective review of 456,930 doses. AJR Am J Roentgenol. 2009 Oct;193(4):1124-7. doi: 10.2214/AJR.09.2520. — View Citation

Kaufman CS, et al., Objective measurement of the physical exam using a new device: reproducible triage of palpable masses. Breast Cancer Research and Treatment, 2004; 88; supp 1:S223-4- SABCS 2004.

Kaufman CS, Jacobson L, Bachman BA, Kaufman LB. Digital documentation of the physical examination: moving the clinical breast exam to the electronic medical record. Am J Surg. 2006 Oct;192(4):444-9. — View Citation

Kaufman CS, Son JS, Yered E, Sarvazyan A. Cancer Res May 1 2015 (75) (9 Supplement) P1- 02-09; DOI:10.1158/1538-7445.SABCS14-P1-02-09

Krouskop 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. — View Citation

Michaelson, 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.

National Center for Health Statistics (NCHS). Health, United States, 2016: With Chartbook on Long-term Trends in Health. Hyattsville, MD. 2017.

Sarvazyan A, Egorov V, Son JS, Kaufman CS. Cost-effective screening for breast cancer worldwide: current state and future directions. Breast Cancer (Auckl). 2008;1:91-9. Epub 2008 Jul 2. — View Citation

Skovoroda, A.R., Klishko, A.N., Gusakyan, D.A., Mayevskii, Y.E., Yermilova, V.D.,Oranskaya, G.A. and Sarvazyan, A.P. 1995. Quantitative analysis of the mechanical characteristics of pathologically changed soft biological tissues. Biophsics, 40(6):1359-64.

Wellman PS, Dalton EP, Krag D, Kern KA, Howe RD. Tactile imaging of breast masses: first clinical report. Arch Surg. 2001 Feb;136(2):204-8. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary	1. This study examines the sensitivity of the SureTouch™ system, compared with methods that are the current standard of care (screening and diagnostic mammography with ultrasound), to detect clinically significant mass lesions in the breast.	2 years
Secondary	Secondary	The study will determine the patient acceptance of and satisfaction with the SureTouch devise. Outcome measure will use an original 8 question Likert-scale survey to assess patient perception of the comfort, duration, and acceptance of the device. A higher score indicates a better outcome.; Brief Survey Monkey adapted from Press Ganey Patient Satisfaction Survey for Radiography and US Performed in the Outpatient Setting. Itri JN. Patient-centered Radiology. RadioGraphics 2015; 35:1835-1848	2 years