Breast CancerDMT SV RRS1NCT03698942
Delphinus SoftVue™ ROC Reader Study
An observational study of Breast Cancer and Breast Neoplasms, run by Delphinus Medical Technologies, Inc. at 1 site in United States.
Trial summary
The purpose of this multi-reader, multi-case (MRMC) reader study is to evaluate reader performance when SoftVue™ automated breast ultrasound and screening mammography are combined, compared to screening mammography alone, in women with dense breast parenchyma. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Cancer, Breast Neoplasms
- What is being tested?
- Reading of Automated Breast Ultrasound in conjunction with Screening Mammography
- Type of treatment
- Medical device
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2018to 23 Sep 2018
- 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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Readers will evaluate mammography and SoftVue images acquired at study entry in protocol DMT 2015.001 and subsequently categorized into the following case types, in random order: * Cancer cases, confirmed by breast biopsy with at least one lesion determined to be malignant during participation * Non-Cancer cases including, but not limited to benign cases, confirmed by breast biopsy with no lesions determined to be malignant, or normal/negative screening or diagnostic imaging during participation
Radiologists of any age, sex, race, ethnicity, or institutional affiliation may participate as study readers. All readers must meet the following Inclusion Criteria:
- Hold a current United States medical license
- Be American Board of Radiology Certified
- Be MQSA-qualified
- Be experienced in reading FFDM images on a monitor (softcopy)
- Be experienced in reading Breast Ultrasound images on a monitor (softcopy)
- Have completed a Financial Disclosure showing no Conflicts of Interest
- Have provided a current curriculum vitae (CV)
- Have provided a signed Readers' Agreement
- Have provided written Informed Consent
All qualified and confirmed readers will complete a multi-module SoftVue™ training program prior to their participation in a reading session for this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective, Observational, Case-Controlled, Multi-Reader, Multi-Case, Receiver Operating Characteristic (ROC) Study of Reader Performance When SoftVue Automated Breast Ultrasound (SV) and Digital Screening Mammography (DM) Are Combined, Compared to Screening Mammography Alone, in Asymptomatic Women With Heterogeneous or Extremely Dense Breast Parenchyma.
The purpose of this multi-reader, multi-case (MRMC) reader study is to evaluate reader performance when SoftVue™ automated breast ultrasound and screening mammography are combined, compared to screening mammography alone, in women with dense breast parenchyma. This includes obtaining information that can be used to properly plan, design, and power future ROC reader studies.
This reader study will include a minimum of 6 radiologist readers and an enriched sample of at least 100 breast screening or diagnostic cases to be selected from the library of images collected under Delphinus Protocol #DMT-2015.001 (NCT03257839). The reader study image case set will be enriched with cancer cases.
- Conditions
- Breast Cancer, Breast Neoplasms
- Being tested
- Reading of Automated Breast Ultrasound in conjunction with Screening Mammography
- Keywords
- Breast Screening, Breast Imaging, SoftVue, Mammography, Ultrasound, Reader Study, ROC AUC, Breast Cancer Detection, Dense Breasts, Breast Density, Dense Breast Tissue, Dense Breast Parenchyma
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reading of Automated Breast Ultrasound in conjunction with Screening MammographyDevice
Also called Digital Screening Mammography with SoftVue Supplemental Screening Whole Breast Ultrasound
Reader performance when SoftVue automated breast ultrasound (SV) and digital screening mammography (DM) are combined, compared to screening mammography alone.
What is being measured
The primary outcome is the main question the study is designed to answer.
MRMC Analysis: ROC AUC
Area under the ROC curve (AUC)
Measured: 8 Weeks
Secondary outcomes (1)
Sensitivity and Specificity
True Positive Rate and True Negative Rate
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start23 Sep 2018
- Primary completion23 Sep 2018
- Study completion23 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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-control
- Time perspective
- Retrospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Delphinus Medical Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Chicago, Biostatistics Consulting, LLC, Reed Technical Associates, LLC
- Responsible party
- Sponsor
- Investigators
- Yulei Jiang, Ph.D, Principal investigator, University of ChicagoMary Ellen Giger, Ph.D, Principal investigator, Univeristy of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03698942
- Sponsor's protocol ID
- DMT-2015.002
- Acronym
- DMT SV RRS1
- Status last verified
- Feb 2020
- First submitted
- 13 Aug 2018
- Last updated
- 7 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, Observational, Case-Controlled, Multi-Reader, Multi-Case, Receiver Operating Characteristic (ROC) Study of Reader Performance When SoftVue Automated Breast Ultrasound (SV) and Digital Screening Mammography (DM) Are Combined, Compared to Screening Mammography Alone, in Asymptomatic Women With Heterogeneous or Extremely Dense Breast Parenchyma.
- ClinicalTrials.gov ID
- NCT03698942
- Acronym / sponsor ID
- DMT SV RRS1 / DMT-2015.002
- Conditions
- Breast Cancer, Breast Neoplasms
- Keywords
- Breast Screening, Breast Imaging, SoftVue, Mammography, Ultrasound, Reader Study, ROC AUC, Breast Cancer Detection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Delphinus Medical Technologies, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Chicago, Biostatistics Consulting, LLC, Reed Technical Associates, LLC
- Study start
- 23 Sep 2018 (actual)
- Primary completion
- 23 Sep 2018 (actual)
- Study completion
- 23 Sep 2018 (actual)
- First posted
- 9 Oct 2018 (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.
The purpose of this multi-reader, multi-case (MRMC) reader study is to evaluate reader performance when SoftVue™ automated breast ultrasound and screening mammography are combined, compared to screening mammography alone, in women with dense breast parenchyma. This includes obtaining information that can be used to properly plan, design, and power future ROC reader studies.
This reader study will include a minimum of 6 radiologist readers and an enriched sample of at least 100 breast screening or diagnostic cases to be selected from the library of images collected under Delphinus Protocol #DMT-2015.001 (NCT03257839). The reader study image case set will be enriched with cancer cases.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Readers will evaluate mammography and SoftVue images acquired at study entry in protocol DMT 2015.001 and subsequently categorized into the following case types, in random order: * Cancer cases, confirmed by breast biopsy with at least one lesion determined to be malignant during participation * Non-Cancer cases including, but not limited to benign cases, confirmed by breast biopsy with no lesions determined to be malignant, or normal/negative screening or diagnostic imaging during participation
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 |
|---|---|---|
| Reading of Automated Breast Ultrasound in conjunction with Screening MammographyAlso: Digital Screening Mammography with SoftVue Supplemental Screening Whole Breast UltrasoundReader performance when SoftVue automated breast ultrasound (SV) and digital screening mammography (DM) are combined, compared to screening mammography alone. | Device | – |
Primary outcome
MRMC Analysis: ROC AUC
Time frame: 8 Weeks
Area under the ROC curve (AUC)
1 secondary outcome
Sensitivity and Specificity
Time frame: 8 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
- 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.
Yulei Jiang, Ph.D principal investigator
University of Chicago
Mary Ellen Giger, Ph.D principal investigator
Univeristy of Chicago
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 and Breast Neoplasms, run by Delphinus Medical Technologies, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
MRMC Analysis: ROC AUC (time frame: 8 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Feb 2020.