Clinical Trials Logo
  1. Home
  2. Breast Cancer
  3. NCT04057391
  4. Details
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
See also
  Status Clinical Trial Phase
Completed NCT04601272 - Evaluating the Shared Decision Making Process Scale in Cancer Screening Decisions
Completed NCT03979729 - Breast Cancer Screening for Underserved Women: Comparing Outcomes and Lowering Recall Rates With 3D- vs. 2D-mammography
Completed NCT02198690 - Trial of a Mammography Decision Aid for Women Aged 75 and Older N/A
Completed NCT01885741 - Study to Demonstrate the Preliminary Safety and Effectiveness of IPBS in Performing MRI-Guided Targeting and Intervention of Breast Tissue in Female Patients Indicated for MRI-Guided Breast Biopsy N/A
Completed NCT01267110 - Engaging Diverse Underserved Communities to Bridge the Mammography Divide N/A
Completed NCT00287040 - Breast Cancer Screening Via Computer V. Phone Phase 3
Recruiting NCT05268224 - A Tear-based, Lab-developed Test for Breast Cancer for Women With Dense Breast Tissue
Completed NCT05821023 - Messaging Strategies to Reduce Breast Cancer Over-screening in Older Women N/A
Recruiting NCT05841355 - Empowering Latinas to Obtain Guideline Concordant Screenings N/A
Recruiting NCT05960188 - Project 1: Self-Triage by 2D Full-field Digital Mammography or Synthetic Images N/A
Recruiting NCT04429269 - A Comparative Study of Mammography and Ultrasound for Breast Cancer Screening and Early Diagnosis
Active, not recruiting NCT03377036 - Breast Cancer Screening: Digital Breast Tomosynthesis Versus Digital 2D Mammography N/A
Completed NCT05756725 - Improving Cancer Screening and Follow-up in Community Health Centers N/A
Enrolling by invitation NCT06059300 - Digital Breast Tomosynthesis for the Dutch National Breast Cancer Screening Program N/A
Completed NCT03046004 - Effect of Information About the Benefits and Harms of Mammography on Women's Decision Making N/A
Completed NCT03517813 - CESM ABMR Breast Cancer Screening Trial
Completed NCT02273206 - Collaborative Care to Reduce Depression and Increase Cancer Screening Among Low-Income Urban Women N/A
Completed NCT00224224 - A Comparison of Primary Care and Traditional Internal Medicine Residents N/A
Recruiting NCT04102722 - Safety and Performance of the Multi-Modal UltraSound Tomography (MUST) Device in Breast Cancer Screening N/A
Completed NCT04259866 - FALSE POSITIVE FINDINGS IN BREAST CANCER TOMOSYNTHESIS

External Links