NCT04397029

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
213

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2019

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 11, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 21, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2021

Completed
Last Updated

June 13, 2022

Status Verified

May 1, 2020

Enrollment Period

2.1 years

First QC Date

March 11, 2020

Last Update Submit

June 9, 2022

Conditions

Breast Cancer

Keywords

BreastScreeningElastography

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Secondary

    2 years

Study Arms (2)

Subjects without messes

EXPERIMENTAL

Subjects who are believed to be free of masses.

Device: SureTouch

Subjects with known masses

EXPERIMENTAL

Subjects with known masses.

Device: SureTouch

Interventions

SureTouchDEVICE

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 massesSubjects without messes

Eligibility Criteria

Age30 Years - 80 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Arm 1:
  • Female Subject presenting for screening mammography
  • years of age, inclusive
  • Able to provide written informed consent
  • Arm 2:
  • Female Subject presenting for diagnostic appointment and/or biopsy
  • years of age, inclusive
  • masses per breast
  • Masses between 0.5 cm and 3.5 cm only

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

George Washington University - Medical Faculty Associates

Washington D.C., District of Columbia, 20037, United States

Location

Related 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.

    BACKGROUND

  • 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/

    PMID: 28910066BACKGROUND

  • 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.

    PMID: 23673574BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 21122101BACKGROUND

  • 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.

    PMID: 8590726BACKGROUND

  • 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.

    PMID: 10197347BACKGROUND

  • 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.

    PMID: 19578481BACKGROUND

  • 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.

    PMID: 16978946BACKGROUND

  • 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.

    PMID: 11177142BACKGROUND

  • 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.

    BACKGROUND

  • 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

    BACKGROUND

  • 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.

    PMID: 19770337BACKGROUND

  • 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.

    PMID: 29489663BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Rebecca Kaltman, MD

    The George Washington University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2020

First Posted

May 21, 2020

Study Start

January 4, 2019

Primary Completion

February 10, 2021

Study Completion

February 10, 2021

Last Updated

June 13, 2022

Record last verified: 2020-05

Locations

US(1)