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Breast CancerNCT04397029

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

A study testing SureTouch in people with Breast Cancer, run by George Washington University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 30 to 80 years, women onlyHealthy volunteers can take part
Conditions the study is for
Breast Cancer
What is being tested?
SureTouch
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
213 participants
Where
1 siteUnited States
Study dates
4 Jan 2019to 10 Feb 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 80 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 30-80 years of age, inclusive
  • 1-3 masses per breast
  • Masses between 0.5 cm and 3.5 cm only

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • George Washington University - Medical Faculty Associates

    Washington D.C., District of Columbia, 20037

Other trials in United States

About this study

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

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.

Read the detailed 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).

Conditions
Breast Cancer
Being tested
SureTouch
Keywords
Breast, Screening, Elastography
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT04397029
Study groupRoleWhat they receive
Subjects without messesExperimentalSubjects who are believed to be free of masses.
Receives: Device: SureTouch
Subjects with known massesExperimentalSubjects with known masses.
Receives: Device: SureTouch

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2 years

Secondary outcomes (1)

  1. 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

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2020
  2. Study start4 Jan 2019
  3. Primary completion10 Feb 2021
  4. Study completion10 Feb 2021

Why it stopped: 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.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
213 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04397029
Sponsor's protocol ID
GW10029
Status last verified
May 2020
First submitted
11 Mar 2020
Last updated
13 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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/

    PubMed 28910066

  • 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.

    PubMed 23673574

  • 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.

    PubMed 21122101

  • 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.

    PubMed 8590726

  • 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.

    PubMed 10197347

  • 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.

    PubMed 19578481

  • 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.

    PubMed 16978946

  • 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.

    PubMed 11177142

  • 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.

    PubMed 19770337

  • 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.

    PubMed 29489663

Questions about this trial

What is this clinical trial studying?

A study testing SureTouch in people with Breast Cancer, run by George Washington University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: 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.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04397029, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2022.

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