Breast NeoplasmsSV PCC ARM1NCT03257839
Delphinus SoftVue Prospective Case Collection - ARM 1
An observational study of Breast Neoplasms, run by Delphinus Medical Technologies, Inc. at 10 sites in United States.
Trial summary
The SoftVue™ is a whole breast ultrasound system with an automated scanning curvilinear ring-array transducer that employs UST. It is currently cleared under FDA 510(k) K123209 and K142517 for use as both a B-mode ultrasonic breast imaging system and color imaging of transmission data (sound speed and attenuation). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Routine Full-Field Digital Mammography, Routine Digital Breast Tomosynthesis and Automated Whole Breast Ultrasound
- Type of treatment
- Medical device
- How many people
- 7,409 participants
- Where
- 10 sitesUnited States
- Study dates
- 31 Jul 2017to 31 Jul 2021
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Asymptomatic women with dense breast tissue
Who may be able to join
- Female
- Any race or ethnicity
- Age 18 or older
- Asymptomatic
- Complete screening FFDM and DBT views
- BI-RADS density composition category c or d
- Willing to comply with protocol and follow-up recommendations as described in consent form, including the next annual screening exam in 12 months
Who cannot join
- Weight exceeds 350lbs
- Currently pregnant or lactating by patient self-report
- Weeping rash, open wounds, or unhealed sores on the breast
- Bilateral mastectomy
- Unable to lay prone on the scan table for up to 15 minutes
- History of breast cancer diagnosis and/or treatment (chemotherapy, surgery, and/or radiation) in the past 12 months
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Ascension St. Elizabeth, Radiology Associates of the Fox Valley
Appleton, Wisconsin, 54911
UNC Breast Imaging Center
Chapel Hill, North Carolina, 27514
Beaumont Dearborn Breast Care Center
Dearborn, Michigan, 48124
Karmanos Cancer Institute
Detroit, Michigan, 48201
USC Keck School of Medicine
Los Angeles, California, 90033
Mount Sinai Medical Center
Miami Beach, Florida, 33140
Weinstein Imaging Associates
Pittsburgh, Pennsylvania, 15220
Elizabeth Wende Breast Care
Rochester, New York, 14620
SouthCoast Imaging
Savannah, Georgia, 31406
Mercy Imaging Services
Washington, Missouri, 93090
About this study
Official title: ARM 1: A Prospective, Multicenter, Multi-arm, Clinical Case Collection Program to Acquire Breast Image Data and Establish an Image Library of Exams for Use in Future Research Studies, Training, and Product Development Efforts.
The SoftVue™ is a whole breast ultrasound system with an automated scanning curvilinear ring-array transducer that employs UST. It is currently cleared under FDA 510(k) K123209 and K142517 for use as both a B-mode ultrasonic breast imaging system and color imaging of transmission data (sound speed and attenuation). SoftVue™ is not intended to be used as a replacement for screening mammography.
SoftVue uses non-ionizing ultrasound energy to generate tomographic image volumes of the whole breast. While the patient lays prone on a padded table with one breast comfortably submerged in a bath of warm water, a ring-shaped transducer, 22 cm in diameter, encircles the breast and pulses low-frequency sound waves through the water and into the breast tissue. More than 2000 elements in the curvilinear transducer's 360 degree array emit and receive ultrasound signals to analyze echoes from the breast anatomy in all directions, from the chest wall to the nipple. Not only does SoftVue capture data from the reflection of the sound waves off of tissue boundaries and structures within the breast, but because the transducer surrounds the whole breast, SoftVue also captures signals that are transmitted through the breast. This additional transmission data enhances the visualization of the anatomic structure of the breast tissue and is not currently available in any other commercially marketed breast ultrasound device.
Read more
This prospective, multicenter, multi-arm, clinical case collection program is IRB-approved and will be conducted in compliance with Good Clinical Practice, the Declaration of Helsinki and all applicable regulatory requirements. Arm 1 aims to collectively enroll up to 17,500 women at a total of up to 8 clinical sites. The design of this protocol is strictly limited to case collection; all investigational and statistical plans for future analyses will be prepared and registered separately, if they are applicable to the requirements of FDAAA 801.
Arm 1 is limited to the cohort of asymptomatic women, with heterogeneously or extremely dense breast parenchyma (BI-RADS breast composition category c or d). Matched triads of 2D digital mammography (FFDM), 3D digital mammography (DBT), and SoftVue automated whole breast ultrasound (SV)exams, from the same patient, with demographic information and clinical outcome data, will be collected during the same screening imaging episode. Ultrasound characteristics for all types of lesions, whether they are benign or malignant, will be collected, as well as objective and subjective breast density composition data.
The exams and clinical data accumulated in this prospective case collection (PCC) protocol will populate a database from which future investigations may be designed for peer reviewed publication, development of user training curriculums, building teaching case, and creating new marketing materials for SoftVue.A subset of exams will be sampled from Arm 1 for use in ROC Reader Study (protocol DMT-2015.002), which will be separately registered and is designed to evaluate the safety and efficacy of a new screening indication for use of SoftVue™ as an adjunct to screening mammography. The results of this ROC Reader Study will be submitted to the FDA for their consideration of a PMA application for SoftVue.
Read the detailed description
MEDICAL DEVICES:
- SoftVue™ (SV) automated whole breast ultrasound system, 510(k) Cleared for B-Mode ultrasound breast imaging, manufactured by Delphinus Medical Technologies.
- SoftVue™ with device modifications (software, hardware, user-interface), safety-tested for human use to complete feasibility, verification, and validation testing as a routine part of product development and performed in accordance with FDA 21 CFR 812.2 (b), manufactured by Delphinus Medical Technologies.
- Full-field digital mammography (FFDM), FDA Approved for breast screening and diagnosis, various manufacturers.
- Digital breast tomosynthesis (DBT), FDA Approved for breast screening and diagnosis, various manufacturers.
OBJECTIVES:
- Primary: To establish a library of cases for use in future SoftVue™ research studies, user training, and marketing.
- Secondary: Determine the frequency and severity of adverse events (AEs) to further evaluate the safety of SoftVue.
ENDPOINTS:
From multiple clinical sites whichever comes first:
- Up to 17,500 total enrolled subjects
- Up to 105 total breast cancer cases detected at program entry screening
- At least 35 total discordant breast cancer cases, where FFDM is negative or benign (BI-RADS 1 or 2) but SV is incomplete (BIRADS 0) and diagnostic imaging workup of SV findings leads to breast biopsy with malignant pathology
SITES:
At least six (≥ 6) qualified clinical sites in the United States
- MQSA Certified
- Digital Breast Tomosynthesis Screening Program Implemented
- Academic, Community Hospital, or Private Practice Setting
PROJECT DESIGN AND PROCEDURES:
- Potential participants will be recruited from the group of women presenting for their annual breast imaging exams at multiple clinical sites utilizing 3D DBT and 2D FFDM (non-synthesized) for routine screening.
- Asymptomatic women with heterogeneously or extremely dense breast parenchyma (BI-RADS composition c or d), based on visual assessment of FFDM by trained site personnel, will be invited to consider volunteering to participate in the case collection program.
- All participants will complete the same routine screening FFDM + DBT evaluation for which they originally reported to the clinic, with a complete set of 2D views and 3D views.
- Eligible patients will receive SV as an adjunct to FFDM + DBT.
- A single Investigator (radiologist) at each site will perform sequential review of the same subjects FFDM, DBT, and SV images.
- FFDM will be evaluated for final parenchymal density (BI-RADS a through d) and then each exam will be assigned to one of 3 BI-RADS assessment categories (0, 1, 2) by the radiologist.
- Abnormal findings will be indicated by a BI-RADS assessment category of 0 (Incomplete)and will undergo diagnostic imaging evaluations consistent with universally accepted standards of care.
- All evaluation results, diagnosis and treatment outcomes will be recorded.
- Normal findings will be indicated by BI-RADS assessment categories of 1 or 2 (Negative or Benign) which will be associated with a management recommendation to resume routine screening in one year, unless symptoms or signs of breast cancer develop in the interim.
- All participants who are not diagnosed with breast cancer as a direct result of the program entry examinations, incidental evaluations, or interval symptoms, will return to the site in 12 months for their next annual screening exam, the results and outcome of which will be recorded.
- Cancer status for all participants will be surveyed from program entry until and including the completion of recommended follow-up.
- A case will be determined cancer negative if the participant has no findings suspicious for cancer throughout the interval between program entry and completion of annual follow-up.
- A case will be determined cancer positive if a pathological evaluation confirms a breast cancer diagnosis during the interval between program entry and completion of annual follow-up.
STATISTICAL ANALYSIS:
- Demographic characteristics (age, race, and ethnicity) and other baseline characteristics (e.g., project arm, project site, breast density, lesion-specific characteristics) will be tabulated for all participants.
- A flow diagram or table will illustrate patient disposition ("accountability of patient cohort") including reasons for ineligibility and/or unevaluability.
- Safety will be summarized for all enrolled women. With the exception of anticipated events, adverse events (AEs) and serious adverse events (SAEs), occurring from the time of enrollment (SoftVue) and for 24 hours following the conclusion of the SoftVue exam, will be recorded.
- A separate statistical plan will be developed for any future analysis that includes justification of sample size and, if applicable to the requirements of FDAAA 801, will be registered separately in order to share the results.
- Conditions
- Breast Neoplasms
- Being tested
- Routine Full-Field Digital Mammography, Routine Digital Breast Tomosynthesis, Automated Whole Breast Ultrasound
- Keywords
- SoftVue, Dense Breast Tissue, Breast Screening, Abnormal Breast, Normal Breast, Breast Imaging, Breast Biopsy, Mammography, Tomosynthesis, Automated Breast Ultrasound, Breast Cancer, Breast Carcinoma, Breast Tumors, Mammary Carcinoma, Malignant Breast Tumor, Mammary Neoplasm, Mammary Cancer, ABUS, AWBUS, Breast Tomography
- Medical subject headings
- Breast Neoplasms, Mammary Neoplasms, Animal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine Full-Field Digital MammographyDevice
Also called FFDM, Digital Mammography, Mammography
Routine screening mammography exam, CC + MLO views.
Routine Digital Breast TomosynthesisDevice
Also called DBT, 3D Mammography, Tomosynthesis
Routine screening tomosynthesis exam, CC + MLO views.
Automated Whole Breast UltrasoundDevice
Also called SoftVue, AWBUS, ABUS, 3D Breast Ultrasound, 3D ABUS, 3D Ultrasound, 3D US
Bilateral breast ultrasound performed as an adjunct to mammography.
| Study group | Role | What they receive |
|---|---|---|
| Asymptomatic women with dense breast tissue | Healthy women presenting to enrollment sites for routine annual mammographic examinations, confirmed to have BI-RADS category c or d breast composition (density). Receives: Device: Routine Full-Field Digital Mammography; Device: Routine Digital Breast Tomosynthesis; Device: Automated Whole Breast Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
No Breast Cancer
Non-Cancer cases, confirmed by normal or negative mammographic breast imaging (FFDM or DBT), or breast biopsy with benign pathology, after at least 365 days of follow-up
Measured: 365 Days
Breast Cancer
Cancer cases, confirmed by breast biopsy with malignant pathology, within 365 days of follow-up
Measured: 365 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start31 Jul 2017
- Primary completion31 Jan 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (50)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 7,409 participants (actual)
Sponsor and investigators
- Lead sponsor
- Delphinus Medical Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mary W Yamashita, MD, Principal investigator, Keck School of Medicine, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03257839
- Sponsor's protocol ID
- DMT-2015.001 ARM 1
- Other IDs
- Protocol ID: 20151525
- Acronym
- SV PCC ARM1
- Status last verified
- Aug 2021
- First submitted
- 18 Aug 2017
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Tabar L, Duffy SW, Vitak B, Chen HH, Prevost TC. The natural history of breast carcinoma: what have we learned from screening? Cancer. 1999 Aug 1;86(3):449-62.
PubMed 10430253Duffy SW, Tabar L, Chen HH, Holmqvist M, Yen MF, Abdsalah S, Epstein B, Frodis E, Ljungberg E, Hedborg-Melander C, Sundbom A, Tholin M, Wiege M, Akerlund A, Wu HM, Tung TS, Chiu YH, Chiu CP, Huang CC, Smith RA, Rosen M, Stenbeck M, Holmberg L. The impact of organized mammography service screening on breast carcinoma mortality in seven Swedish counties. Cancer. 2002 Aug 1;95(3):458-69. doi: 10.1002/cncr.10765.
PubMed 12209737Duffy SW, Smith RA, Gabe R, Tabar L, Yen AM, Chen TH. Screening for breast cancer. Surg Oncol Clin N Am. 2005 Oct;14(4):671-97. doi: 10.1016/j.soc.2005.06.001.
PubMed 16226686Paci E, Duffy SW, Giorgi D, Zappa M, Crocetti E, Vezzosi V, Bianchi S, del Turco MR. Quantification of the effect of mammographic screening on fatal breast cancers: The Florence Programme 1990-96. Br J Cancer. 2002 Jul 1;87(1):65-9. doi: 10.1038/sj.bjc.6600301.
PubMed 12085258Tabar L, Duffy SW, Yen MF, Warwick J, Vitak B, Chen HH, Smith RA. All-cause mortality among breast cancer patients in a screening trial: support for breast cancer mortality as an end point. J Med Screen. 2002;9(4):159-62. doi: 10.1136/jms.9.4.159.
PubMed 12518005Swedish Organised Service Screening Evaluation Group. Effect of mammographic service screening on stage at presentation of breast cancers in Sweden. Cancer. 2007 Jun 1;109(11):2205-12. doi: 10.1002/cncr.22671.
PubMed 17471486Swedish Organised Service Screening Evaluation Group. Reduction in breast cancer mortality from organized service screening with mammography: 1. Further confirmation with extended data. Cancer Epidemiol Biomarkers Prev. 2006 Jan;15(1):45-51. doi: 10.1158/1055-9965.EPI-05-0349.
PubMed 16434585Swedish Organised Service Screening Evaluation Group. Reduction in breast cancer mortality from the organised service screening with mammography: 2. Validation with alternative analytic methods. Cancer Epidemiol Biomarkers Prev. 2006 Jan;15(1):52-6. doi: 10.1158/1055-9965.EPI-05-0953.
PubMed 16434586Hakama M, Pukkala E, Heikkila M, Kallio M. Effectiveness of the public health policy for breast cancer screening in Finland: population based cohort study. BMJ. 1997 Mar 22;314(7084):864-7. doi: 10.1136/bmj.314.7084.864.
PubMed 9093096Tabar L, Vitak B, Chen TH, Yen AM, Cohen A, Tot T, Chiu SY, Chen SL, Fann JC, Rosell J, Fohlin H, Smith RA, Duffy SW. Swedish two-county trial: impact of mammographic screening on breast cancer mortality during 3 decades. Radiology. 2011 Sep;260(3):658-63. doi: 10.1148/radiol.11110469. Epub 2011 Jun 28.
PubMed 21712474Michaelson JS, Silverstein M, Wyatt J, Weber G, Moore R, Halpern E, Kopans DB, Hughes K. Predicting the survival of patients with breast carcinoma using tumor size. Cancer. 2002 Aug 15;95(4):713-23. doi: 10.1002/cncr.10742.
PubMed 12209713Smith RA, Duffy SW, Gabe R, Tabar L, Yen AM, Chen TH. The randomized trials of breast cancer screening: what have we learned? Radiol Clin North Am. 2004 Sep;42(5):793-806, v. doi: 10.1016/j.rcl.2004.06.014.
PubMed 15337416Kolb TM, Lichy J, Newhouse JH. Comparison of the performance of screening mammography, physical examination, and breast US and evaluation of factors that influence them: an analysis of 27,825 patient evaluations. Radiology. 2002 Oct;225(1):165-75. doi: 10.1148/radiol.2251011667.
PubMed 12355001Kerlikowske K, Grady D, Barclay J, Sickles EA, Ernster V. Effect of age, breast density, and family history on the sensitivity of first screening mammography. JAMA. 1996 Jul 3;276(1):33-8.
PubMed 8667536Pisano ED, Gatsonis C, Hendrick E, Yaffe M, Baum JK, Acharyya S, Conant EF, Fajardo LL, Bassett L, D'Orsi C, Jong R, Rebner M; Digital Mammographic Imaging Screening Trial (DMIST) Investigators Group. Diagnostic performance of digital versus film mammography for breast-cancer screening. N Engl J Med. 2005 Oct 27;353(17):1773-83. doi: 10.1056/NEJMoa052911. Epub 2005 Sep 16.
PubMed 16169887
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ARM 1: A Prospective, Multicenter, Multi-arm, Clinical Case Collection Program to Acquire Breast Image Data and Establish an Image Library of Exams for Use in Future Research Studies, Training, and Product Development Efforts.
- ClinicalTrials.gov ID
- NCT03257839
- Acronym / sponsor ID
- SV PCC ARM1 / DMT-2015.001 ARM 1
- Conditions
- Breast Neoplasms
- Keywords
- SoftVue, Dense Breast Tissue, Breast Screening, Abnormal Breast, Normal Breast, Breast Imaging, Breast Biopsy, Mammography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,409 participants (actual)
- Lead sponsor
- Delphinus Medical Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Jul 2017 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 22 Aug 2017 (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 SoftVue™ is a whole breast ultrasound system with an automated scanning curvilinear ring-array transducer that employs UST. It is currently cleared under FDA 510(k) K123209 and K142517 for use as both a B-mode ultrasonic breast imaging system and color imaging of transmission data (sound speed and attenuation). SoftVue™ is not intended to be used as a replacement for screening mammography.
SoftVue uses non-ionizing ultrasound energy to generate tomographic image volumes of the whole breast. While the patient lays prone on a padded table with one breast comfortably submerged in a bath of warm water, a ring-shaped transducer, 22 cm in diameter, encircles the breast and pulses low-frequency sound waves through the water and into the breast tissue. More than 2000 elements in the curvilinear transducer's 360 degree array emit and receive ultrasound signals to analyze echoes from the breast anatomy in all directions, from the chest wall to the nipple. Not only does SoftVue capture data from the reflection of the sound waves off of tissue boundaries and structures within the breast, but because the transducer surrounds the whole breast, SoftVue also captures signals that are transmitted through the breast. This additional transmission data enhances the visualization of the anatomic structure of the breast tissue and is not currently available in any other commercially marketed breast ultrasound device.
This prospective, multicenter, multi-arm, clinical case collection program is IRB-approved and will be conducted in compliance with Good Clinical Practice, the Declaration of Helsinki and all applicable regulatory requirements. Arm 1 aims to collectively enroll up to 17,500 women at a total of up to 8 clinical sites. The design of this protocol is strictly limited to case collection; all investigational and statistical plans for future analyses will be prepared and registered separately, if they are applicable to the requirements of FDAAA 801.
Arm 1 is limited to the cohort of asymptomatic women, with heterogeneously or extremely dense breast parenchyma (BI-RADS breast composition category c or d). Matched triads of 2D digital mammography (FFDM), 3D digital mammography (DBT), and SoftVue automated whole breast ultrasound (SV)exams, from the same patient, with demographic information and clinical outcome data, will be collected during the same screening imaging episode. Ultrasound characteristics for all types of lesions, whether they are benign or malignant, will be collected, as well as objective and subjective breast density composition data.
The exams and clinical data accumulated in this prospective case collection (PCC) protocol will populate a database from which future investigations may be designed for peer reviewed publication, development of user training curriculums, building teaching case, and creating new marketing materials for SoftVue.A subset of exams will be sampled from Arm 1 for use in ROC Reader Study (protocol DMT-2015.002), which will be separately registered and is designed to evaluate the safety and efficacy of a new screening indication for use of SoftVue™ as an adjunct to screening mammography. The results of this ROC Reader Study will be submitted to the FDA for their consideration of a PMA application for SoftVue.
Detailed description
MEDICAL DEVICES:
- SoftVue™ (SV) automated whole breast ultrasound system, 510(k) Cleared for B-Mode ultrasound breast imaging, manufactured by Delphinus Medical Technologies.
- SoftVue™ with device modifications (software, hardware, user-interface), safety-tested for human use to complete feasibility, verification, and validation testing as a routine part of product development and performed in accordance with FDA 21 CFR 812.2 (b), manufactured by Delphinus Medical Technologies.
- Full-field digital mammography (FFDM), FDA Approved for breast screening and diagnosis, various manufacturers.
- Digital breast tomosynthesis (DBT), FDA Approved for breast screening and diagnosis, various manufacturers.
OBJECTIVES:
- Primary: To establish a library of cases for use in future SoftVue™ research studies, user training, and marketing.
- Secondary: Determine the frequency and severity of adverse events (AEs) to further evaluate the safety of SoftVue.
ENDPOINTS:
From multiple clinical sites whichever comes first:
- Up to 17,500 total enrolled subjects
- Up to 105 total breast cancer cases detected at program entry screening
- At least 35 total discordant breast cancer cases, where FFDM is negative or benign (BI-RADS 1 or 2) but SV is incomplete (BIRADS 0) and diagnostic imaging workup of SV findings leads to breast biopsy with malignant pathology
SITES:
At least six (≥ 6) qualified clinical sites in the United States
- MQSA Certified
- Digital Breast Tomosynthesis Screening Program Implemented
- Academic, Community Hospital, or Private Practice Setting
PROJECT DESIGN AND PROCEDURES:
- Potential participants will be recruited from the group of women presenting for their annual breast imaging exams at multiple clinical sites utilizing 3D DBT and 2D FFDM (non-synthesized) for routine screening.
- Asymptomatic women with heterogeneously or extremely dense breast parenchyma (BI-RADS composition c or d), based on visual assessment of FFDM by trained site personnel, will be invited to consider volunteering to participate in the case collection program.
- All participants will complete the same routine screening FFDM + DBT evaluation for which they originally reported to the clinic, with a complete set of 2D views and 3D views.
- Eligible patients will receive SV as an adjunct to FFDM + DBT.
- A single Investigator (radiologist) at each site will perform sequential review of the same subjects FFDM, DBT, and SV images.
- FFDM will be evaluated for final parenchymal density (BI-RADS a through d) and then each exam will be assigned to one of 3 BI-RADS assessment categories (0, 1, 2) by the radiologist.
- Abnormal findings will be indicated by a BI-RADS assessment category of 0 (Incomplete)and will undergo diagnostic imaging evaluations consistent with universally accepted standards of care.
- All evaluation results, diagnosis and treatment outcomes will be recorded.
- Normal findings will be indicated by BI-RADS assessment categories of 1 or 2 (Negative or Benign) which will be associated with a management recommendation to resume routine screening in one year, unless symptoms or signs of breast cancer develop in the interim.
- All participants who are not diagnosed with breast cancer as a direct result of the program entry examinations, incidental evaluations, or interval symptoms, will return to the site in 12 months for their next annual screening exam, the results and outcome of which will be recorded.
- Cancer status for all participants will be surveyed from program entry until and including the completion of recommended follow-up.
- A case will be determined cancer negative if the participant has no findings suspicious for cancer throughout the interval between program entry and completion of annual follow-up.
- A case will be determined cancer positive if a pathological evaluation confirms a breast cancer diagnosis during the interval between program entry and completion of annual follow-up.
STATISTICAL ANALYSIS:
- Demographic characteristics (age, race, and ethnicity) and other baseline characteristics (e.g., project arm, project site, breast density, lesion-specific characteristics) will be tabulated for all participants.
- A flow diagram or table will illustrate patient disposition ("accountability of patient cohort") including reasons for ineligibility and/or unevaluability.
- Safety will be summarized for all enrolled women. With the exception of anticipated events, adverse events (AEs) and serious adverse events (SAEs), occurring from the time of enrollment (SoftVue) and for 24 hours following the conclusion of the SoftVue exam, will be recorded.
- A separate statistical plan will be developed for any future analysis that includes justification of sample size and, if applicable to the requirements of FDAAA 801, will be registered separately in order to share the results.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asymptomatic women with dense breast tissue | – | Device: Routine Full-Field Digital Mammography, Device: Routine Digital Breast Tomosynthesis, Device: Automated Whole Breast UltrasoundHealthy women presenting to enrollment sites for routine annual mammographic examinations, confirmed to have BI-RADS category c or d breast composition (density). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Asymptomatic women with dense breast tissue
Key inclusion criteria (7 listed)
- Female
- Any race or ethnicity
- Age 18 or older
- Asymptomatic
- Complete screening FFDM and DBT views
Key exclusion criteria (6 listed)
- Weight exceeds 350lbs
- Currently pregnant or lactating by patient self-report
- Weeping rash, open wounds, or unhealed sores on the breast
- Bilateral mastectomy
- Unable to lay prone on the scan table for up to 15 minutes
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 |
|---|---|---|
| Routine Full-Field Digital MammographyAlso: FFDM, Digital Mammography, MammographyRoutine screening mammography exam, CC + MLO views. | Device | Asymptomatic women with dense breast tissue |
| Routine Digital Breast TomosynthesisAlso: DBT, 3D Mammography, TomosynthesisRoutine screening tomosynthesis exam, CC + MLO views. | Device | Asymptomatic women with dense breast tissue |
| Automated Whole Breast UltrasoundAlso: SoftVue, AWBUS, ABUS, 3D Breast Ultrasound, 3D ABUS, 3D Ultrasound, 3D USBilateral breast ultrasound performed as an adjunct to mammography. | Device | Asymptomatic women with dense breast tissue |
Primary outcome
No Breast Cancer
Time frame: 365 Days
Non-Cancer cases, confirmed by normal or negative mammographic breast imaging (FFDM or DBT), or breast biopsy with benign pathology, after at least 365 days of follow-up
Breast Cancer
Time frame: 365 Days
Cancer cases, confirmed by breast biopsy with malignant pathology, within 365 days of follow-up
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 5 Sep 2021.
- Background: PubMed 10430253Tabar L, Duffy SW, Vitak B, Chen HH, Prevost TC. The natural history of breast carcinoma: what have we learned from screening? Cancer. 1999 Aug 1;86(3):449-62.
- Background: PubMed 12209737Duffy SW, Tabar L, Chen HH, Holmqvist M, Yen MF, Abdsalah S, Epstein B, Frodis E, Ljungberg E, Hedborg-Melander C, Sundbom A, Tholin M, Wiege M, Akerlund A, Wu HM, Tung TS, Chiu YH, Chiu CP, Huang CC, Smith RA, Rosen M, Stenbeck M, Holmberg L. The impact of organized mammography service screening on breast carcinoma mortality in seven Swedish counties. Cancer. 2002 Aug 1;95(3):458-69. doi: 10.1002/cncr.10765.
- Background: PubMed 16226686Duffy SW, Smith RA, Gabe R, Tabar L, Yen AM, Chen TH. Screening for breast cancer. Surg Oncol Clin N Am. 2005 Oct;14(4):671-97. doi: 10.1016/j.soc.2005.06.001.
- Background: PubMed 12085258Paci E, Duffy SW, Giorgi D, Zappa M, Crocetti E, Vezzosi V, Bianchi S, del Turco MR. Quantification of the effect of mammographic screening on fatal breast cancers: The Florence Programme 1990-96. Br J Cancer. 2002 Jul 1;87(1):65-9. doi: 10.1038/sj.bjc.6600301.
- Background: PubMed 12518005Tabar L, Duffy SW, Yen MF, Warwick J, Vitak B, Chen HH, Smith RA. All-cause mortality among breast cancer patients in a screening trial: support for breast cancer mortality as an end point. J Med Screen. 2002;9(4):159-62. doi: 10.1136/jms.9.4.159.
- Background: PubMed 17471486Swedish Organised Service Screening Evaluation Group. Effect of mammographic service screening on stage at presentation of breast cancers in Sweden. Cancer. 2007 Jun 1;109(11):2205-12. doi: 10.1002/cncr.22671.
- Background: PubMed 16434585Swedish Organised Service Screening Evaluation Group. Reduction in breast cancer mortality from organized service screening with mammography: 1. Further confirmation with extended data. Cancer Epidemiol Biomarkers Prev. 2006 Jan;15(1):45-51. doi: 10.1158/1055-9965.EPI-05-0349.
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- Background: PubMed 9093096Hakama M, Pukkala E, Heikkila M, Kallio M. Effectiveness of the public health policy for breast cancer screening in Finland: population based cohort study. BMJ. 1997 Mar 22;314(7084):864-7. doi: 10.1136/bmj.314.7084.864.
- Background: PubMed 21712474Tabar L, Vitak B, Chen TH, Yen AM, Cohen A, Tot T, Chiu SY, Chen SL, Fann JC, Rosell J, Fohlin H, Smith RA, Duffy SW. Swedish two-county trial: impact of mammographic screening on breast cancer mortality during 3 decades. Radiology. 2011 Sep;260(3):658-63. doi: 10.1148/radiol.11110469. Epub 2011 Jun 28.
- Background: PubMed 12209713Michaelson JS, Silverstein M, Wyatt J, Weber G, Moore R, Halpern E, Kopans DB, Hughes K. Predicting the survival of patients with breast carcinoma using tumor size. Cancer. 2002 Aug 15;95(4):713-23. doi: 10.1002/cncr.10742.
- Background: PubMed 15337416Smith RA, Duffy SW, Gabe R, Tabar L, Yen AM, Chen TH. The randomized trials of breast cancer screening: what have we learned? Radiol Clin North Am. 2004 Sep;42(5):793-806, v. doi: 10.1016/j.rcl.2004.06.014.
- Delphinus Medical TechnologiesLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Mary W Yamashita, MD principal investigator
Keck School of Medicine, University of Southern California
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms, run by Delphinus Medical Technologies, Inc. at 10 sites 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 7 inclusion and 6 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: finished, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
No Breast Cancer (time frame: 365 Days). The study lists 2 primary outcomes in all. 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 NCT03257839, which also lists 50 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 5 Sep 2021.