Breast Cancer ScreeningNCT04057391
Understanding Patient Experience and Preferences for the QT Scanner Compared to Mammography
An observational study of Breast Cancer Screening, run by QT Ultrasound LLC at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Screening
- What is being tested?
- QT Scanner
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2019to 30 Dec 2022
- Phase
- Observational
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study target population are women who have experience with both the QT Scanner and mammography.
Who may be able to join
- Have used the QT Scanner
- Have used mammography
- Speak English
- Willing to provide consent and participate in the survey
Who cannot join
- Excluded if all Inclusion Criteria are not met
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Breast Cancer Screening
- Being tested
- QT Scanner
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QT ScannerDiagnostic test
Also called Quantitative Transmission Ultrasound Breast Scanner-1
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.
| Study group | Role | What they receive |
|---|---|---|
| QT Scanner in comparison to mammography | Women who have experience with both technologies (QT Scanner/Breast mammography Receives: Diagnostic Test: QT Scanner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative phase: structured one-on-one interviews
one-on-one interviews will be conducted by trained professionals with about 20 women
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study start6 Aug 2019
- Primary completion30 Aug 2019
- Study completion30 Dec 2022 (estimated)
Why it stopped: This study was suspended by QTultrasound as other studies were reprioritized.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer ScreeningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- QT Ultrasound LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Analysis Group, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04057391
- Sponsor's protocol ID
- QT MG PRE Phase 1
- Status last verified
- Apr 2022
- First submitted
- 13 Aug 2019
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 14627058Blumen 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.
PubMed 27066193Johnson 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.
PubMed 27712700
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Patient Experience and Preferences for the QT Scanner Compared to Mammography
- ClinicalTrials.gov ID
- NCT04057391
- Acronym / sponsor ID
- QT MG PRE Phase 1
- Conditions
- Breast Cancer Screening
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: This study was suspended by QTultrasound as other studies were reprioritized.
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- QT Ultrasound LLCIndustry (pharma, biotech, devices)
- Collaborators
- Analysis Group, Inc.
- Study start
- 6 Aug 2019 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 15 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QT Scanner in comparison to mammography | – | Diagnostic Test: QT ScannerWomen who have experience with both technologies (QT Scanner/Breast mammography |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study target population are women who have experience with both the QT Scanner and mammography.
Key inclusion criteria (4 listed)
- Have used the QT Scanner
- Have used mammography
- Speak English
- Willing to provide consent and participate in the survey
Key exclusion criteria (1 listed)
- Excluded if all Inclusion Criteria are not met
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QT ScannerAlso: Quantitative Transmission Ultrasound Breast Scanner-1Diagnostic 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. | Diagnostic test | QT Scanner in comparison to mammography |
Primary outcome
Qualitative phase: structured one-on-one interviews
Time frame: 30 days
one-on-one interviews will be conducted by trained professionals with about 20 women
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Background: PubMed 14627058Acquadro 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.
- Background: PubMed 27066193Blumen 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.
- Background: PubMed 27712700Johnson 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.
- National Cancer Institute S, Epidemiology, and End Results Program,. Cancer Stat Facts: Female Breast Cancer.Link provided by the sponsor.
- National Breast Cancer Foundation I. Facts about breast cancer in the United States. 2019Link provided by the sponsor.
- American Cancer Society. Breast Cancer Facts \& Figures 2017-2018.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Screening, run by QT Ultrasound LLC 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 4 inclusion and 1 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: paused, as of the sponsor's last update on 27 Apr 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?
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?
Qualitative phase: structured one-on-one interviews (time frame: 30 days). 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 NCT04057391, which also lists 3 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 27 Apr 2022.