Understanding Patient Experience and Preferences for the QT Scanner Compared to Mammography

NCT ID: NCT04057391

Last Updated: 2022-04-27

Study Results

Results pending

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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Recruitment Status

SUSPENDED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-06

Study Completion Date

2022-12-30

Brief Summary

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This study aims to characterize patient experience, satisfaction and preference for use of the QT Scanner in comparison to mammography by directly engaging women who have experience with both technologies.

Detailed Description

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The objectives will be addressed by first conducting structured one-on-one interviews with about 20 women (Qualitative Phase), and then administering a web-based patient survey with quantitative measurements in about 200 women (Quantitative Phase). The current Protocol registration pertains to the first, qualitative phase of the study.

Conditions

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Breast Cancer Screening

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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QT Scanner in comparison to mammography

Women who have experience with both technologies (QT Scanner/Breast mammography

QT Scanner

Intervention Type DIAGNOSTIC_TEST

Diagnostic test that is repeatable, non-invasive imaging tool for the early and accurate detection of breast cancer, breast abnormalities, and musculoskeletal findings. Comparing with mammography, the QT Scanner uses harmless soundwaves to screen and diagnose the breast.

Interventions

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QT Scanner

Diagnostic test that is repeatable, non-invasive imaging tool for the early and accurate detection of breast cancer, breast abnormalities, and musculoskeletal findings. Comparing with mammography, the QT Scanner uses harmless soundwaves to screen and diagnose the breast.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Quantitative Transmission Ultrasound Breast Scanner-1

Eligibility Criteria

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Inclusion Criteria

* Have used the QT Scanner
* Have used mammography
* Speak English
* Willing to provide consent and participate in the survey
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Analysis Group, Inc.

INDUSTRY

Sponsor Role collaborator

QT Ultrasound LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Analysis Group, Inc.

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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Acquadro C, Berzon R, Dubois D, Leidy NK, Marquis P, Revicki D, Rothman M; PRO Harmonization Group. Incorporating the patient's perspective into drug development and communication: an ad hoc task force report of the Patient-Reported Outcomes (PRO) Harmonization Group meeting at the Food and Drug Administration, February 16, 2001. Value Health. 2003 Sep-Oct;6(5):522-31. doi: 10.1046/j.1524-4733.2003.65309.x.

Reference Type BACKGROUND
PMID: 14627058 (View on PubMed)

Blumen H, Fitch K, Polkus V. Comparison of Treatment Costs for Breast Cancer, by Tumor Stage and Type of Service. Am Health Drug Benefits. 2016 Feb;9(1):23-32.

Reference Type BACKGROUND
PMID: 27066193 (View on PubMed)

Johnson FR, Zhou M. Patient Preferences in Regulatory Benefit-Risk Assessments: A US Perspective. Value Health. 2016 Sep-Oct;19(6):741-745. doi: 10.1016/j.jval.2016.04.008.

Reference Type BACKGROUND
PMID: 27712700 (View on PubMed)

Related Links

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https://seer.cancer.gov/statfacts/html/breast.html

National Cancer Institute S, Epidemiology, and End Results Program,. Cancer Stat Facts: Female Breast Cancer.

https://www.nationalbreastcancer.org/breast-cancer-facts

National Breast Cancer Foundation I. Facts about breast cancer in the United States. 2019

Other Identifiers

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QT MG PRE Phase 1

Identifier Type: -

Identifier Source: org_study_id

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