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

NCT04057391 | Suspended FDA Device

• 1 other identifier: QT MG PRE Phase 1
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer Screening

Outcome Measures

Primary Outcomes (1)

• Qualitative phase: structured one-on-one interviews

  one-on-one interviews will be conducted by trained professionals with about 20 women

  30 days

Study Arms (1)

QT Scanner in comparison to mammography

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

Diagnostic Test: QT Scanner

Interventions

QT Scanner 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.

Also known as: Quantitative Transmission Ultrasound Breast Scanner-1

QT Scanner in comparison to mammography

Eligibility Criteria

• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study target population are women who have experience with both the QT Scanner and mammography.

You may qualify if:

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

Sponsors & Collaborators

• QT Ultrasound LLC: lead
• Analysis Group, Inc.: collaborator

Study Sites (1)

Analysis Group, Inc.

Boston, Massachusetts, 02199, United States

Location

Related 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. doi: 10.1046/j.1524-4733.2003.65309.x.

  PMID: 14627058 BACKGROUND

• 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.

  PMID: 27066193 BACKGROUND

• 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.

  PMID: 27712700 BACKGROUND

Related Links

• National Cancer Institute S, Epidemiology, and End Results Program,. Cancer Stat Facts: Female Breast Cancer.
• National Breast Cancer Foundation I. Facts about breast cancer in the United States. 2019
• American Cancer Society. Breast Cancer Facts \& Figures 2017-2018.

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2019
• First Posted: August 15, 2019
• Study Start: August 6, 2019
• Primary Completion: August 30, 2019
• Study Completion: December 30, 2022
• Last Updated: April 27, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)