Breast Cancer DetectionDMT SV RRS3NCT04260620
Delphinus SoftVue™ ROC Reader Study (DMT SV RRS3)
An observational study of Breast Cancer Detection and Dense Breast Parenchyma, 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 Detection, Dense Breast Parenchyma, Benign Breast Findings
- What is being tested?
- Reading of Automated Breast Ultrasound in conjunction with Screening Mammography
- Type of treatment
- Medical device
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2020to 3 Mar 2020
- 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 from consented participants 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 base Inclusion Criteria:
- Hold a current United States medical license
- Be American Board of Radiology Certified
- Be MQSA-qualified
- Be experienced in reading DM images on a monitor
- Be experienced in reading Breast Ultrasound images on a monitor
- 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.
United States1 site
Delphinus Medical Technologies, Inc.
Novi, Michigan, 48374
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 reader study will include up to 32 radiologist readers and a sample of 140 breast screening cases that were selected from the library of images collected under Delphinus Protocol #DMT-2015.001 (NCT03257839) Arm 1 Phase B. The reader study image case set will be enriched with cancer cases.
- Conditions
- Breast Cancer Detection, Dense Breast Parenchyma, Benign Breast Findings, Normal Breast Screening, Abnormal Breast Screening
- Being tested
- Reading of Automated Breast Ultrasound in conjunction with Screening Mammography
- Keywords
- Breast Screening, Breast Imaging, SoftVue, Mammography, Ultrasound, Reader Study, ROC AUC, Dense Breasts, Breast Density, Dense Breast Tissue, Breast Neoplasms
- 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 Adjunctive SoftVue 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 posted7 Feb 2020
- Study start8 Feb 2020
- Primary completion3 Mar 2020
- Study completion3 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer DetectionStudies 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Delphinus Medical Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Chicago, Boston Biomedical Associates
- Responsible party
- Sponsor
- Investigators
- Yulei Jiang, Ph.D, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04260620
- Sponsor's protocol ID
- DMT-2019.002
- Acronym
- DMT SV RRS3
- Status last verified
- Feb 2021
- First submitted
- 5 Feb 2020
- Last updated
- 3 Feb 2021
- 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 3 Feb 2021. 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
- NCT04260620
- Acronym / sponsor ID
- DMT SV RRS3 / DMT-2019.002
- Conditions
- Breast Cancer Detection, Dense Breast Parenchyma, Benign Breast Findings, Normal Breast Screening, Abnormal Breast Screening
- Keywords
- Breast Screening, Breast Imaging, SoftVue, Mammography, Ultrasound, Reader Study, ROC AUC, Dense Breasts
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Delphinus Medical Technologies, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Chicago, Boston Biomedical Associates
- Study start
- 8 Feb 2020 (actual)
- Primary completion
- 3 Mar 2020 (actual)
- Study completion
- 3 Mar 2020 (actual)
- First posted
- 7 Feb 2020 (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 reader study will include up to 32 radiologist readers and a sample of 140 breast screening cases that were selected from the library of images collected under Delphinus Protocol #DMT-2015.001 (NCT03257839) Arm 1 Phase B. 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 from consented participants 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 Adjunctive SoftVue 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 3 Feb 2021.
- 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
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 Detection and Dense Breast Parenchyma, 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 3 Feb 2021. 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 3 Feb 2021.