Assessing the Sensitivity of "SureTouch™" in Women Undergoing Diagnostic and Screening Mammography
NCT ID: NCT04397029
Last Updated: 2022-06-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
213 participants
INTERVENTIONAL
2019-01-04
2021-02-10
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SCREENING
SINGLE
Study Groups
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Subjects without messes
Subjects who are believed to be free of masses.
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.
Subjects with known masses
Subjects with known masses.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
30 Years
80 Years
FEMALE
Yes
Sponsors
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Sure, Inc.
INDUSTRY
George Washington University
OTHER
Responsible Party
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Principal Investigators
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Rebecca Kaltman, MD
Role: PRINCIPAL_INVESTIGATOR
The George Washington University
Locations
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George Washington University - Medical Faculty Associates
Washington D.C., District of Columbia, United States
Countries
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References
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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.
National 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/
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.
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.
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.
Skovorda 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.
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. doi: 10.1177/016173469802000403.
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. doi: 10.4137/bcbcr.s774. Epub 2008 Jul 2.
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. doi: 10.1016/j.amjsurg.2006.06.006.
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. doi: 10.1001/archsurg.136.2.204.
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, 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
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.
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.
Other Identifiers
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GW10029
Identifier Type: -
Identifier Source: org_study_id
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