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NCT04057391 Clinical Trial

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

Breast Cancer Screening Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data
NCT number NCT04057391
Other study ID # QT MG PRE Phase 1
Secondary ID
Status Suspended
Phase
First received
Last updated
Start date August 6, 2019
Est. completion date December 30, 2022

Study information
Verified date April 2022
Source QT Ultrasound LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Suspended
Enrollment 20
Est. completion date December 30, 2022
Est. primary completion date August 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: - Have used the QT Scanner - Have used mammography - Speak English - Willing to provide consent and participate in the survey Exclusion Criteria: • Excluded if all Inclusion Criteria are not met

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• 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.

Locations
Country Name City State
United States Analysis Group, Inc. Boston Massachusetts

Sponsors (2)
Lead Sponsor Collaborator
QT Ultrasound LLC Analysis Group, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Qualitative phase: structured one-on-one interviews one-on-one interviews will be conducted by trained professionals with about 20 women 30 days
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