Delphinus SoftVue Prospective Case Collection - ARM 1
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Breast Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/11/2018 |
| Start Date: | July 31, 2017 |
| End Date: | December 2019 |
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.
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.
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.
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.
- 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.
Inclusion Criteria
- 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
Exclusion Criteria
- 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
We found this trial at
7
sites
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Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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18100 Oakwood
Dearborn, Michigan 48124
Dearborn, Michigan 48124
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Los Angeles, California 90033
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