Delphinus SoftVue Prospective Case Collection - ARM 2
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Breast Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/11/2018 |
| Start Date: | November 2016 |
| End Date: | December 2018 |
ARM 2: 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 2 aims to collectively enroll up to 1,000
women at a total of up to 8 clinical sites. The design of Arm 2 in this protocol is strictly
limited to case collection and is non-interventional; any investigational and/or statistical
plans for future analyses will be prepared and registered separately, if they are applicable
to the requirements of FDAAA 801.
Arm 2 is limited to the cohort of diagnostic female patients of any breast density
composition category, who have been recommended for a breast biopsy (BI-RADS 4 or 5) after
diagnostic imaging, or who have confirmed imaging findings. Matched sets of diagnostic
imaging and SV exams, from the same patient, demographic information, and clinical outcome
data, will be collected during diagnostic workup. 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. Ultrasound image data may be acquired with
modified SoftVue devices, which have passed safety and quality evaluations per Delphinus'
quality management system (QMS) and satisfy design change control standards, at select
clinical sites in accordance with 21 CFR 812.2 (b), as a routine part of feasibility,
validation, and verification testing for engineering and product development purposes.
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 curricula, building teaching case, and creating new
marketing materials 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 2 aims to collectively enroll up to 1,000
women at a total of up to 8 clinical sites. The design of Arm 2 in this protocol is strictly
limited to case collection and is non-interventional; any investigational and/or statistical
plans for future analyses will be prepared and registered separately, if they are applicable
to the requirements of FDAAA 801.
Arm 2 is limited to the cohort of diagnostic female patients of any breast density
composition category, who have been recommended for a breast biopsy (BI-RADS 4 or 5) after
diagnostic imaging, or who have confirmed imaging findings. Matched sets of diagnostic
imaging and SV exams, from the same patient, demographic information, and clinical outcome
data, will be collected during diagnostic workup. 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. Ultrasound image data may be acquired with
modified SoftVue devices, which have passed safety and quality evaluations per Delphinus'
quality management system (QMS) and satisfy design change control standards, at select
clinical sites in accordance with 21 CFR 812.2 (b), as a routine part of feasibility,
validation, and verification testing for engineering and product development purposes.
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 curricula, building teaching case, and creating new
marketing materials 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. (If clinically indicated)
- Digital breast tomosynthesis (DBT), FDA Approved for breast screening and diagnosis,
various manufacturers.
- Handheld Ultrasound (HHUS), FDA-Cleared for diagnostic breast imaging, various
manufacturers. (If clinically indicated)
- Other diagnostic tests and medical device examinations of the breast, including, but not
limited to MRI, BSGI, PET, biopsy, and elastography, on the order of a licensed
physician, when clinically indicated.
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 1,000 total enrolled subjects
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
diagnostic evaluation or biopsy at multiple clinical sites.
- All participants will complete the same standard care diagnostic evaluations that were
recommended by a physician
- Eligible patients will receive a SV scan at the time of their scheduled diagnostic
appointments, preferably prior to biopsy
- Investigators at the sites will compare SV images to the accompanying diagnostic images
and pathology results
- No clinical SV interpretation will be performed and no clinical interventions will be
made or changed based on SV images
- All evaluation results, diagnosis and treatment outcomes will be recorded
- Cancer status for all participants will be surveyed from program entry until and
including the completion of physician recommended diagnostic workup
- A case will be determined cancer negative if the participant has non-malignant breast
biopsy findings or confirmed non-suspicious diagnostic breast imaging findings
- A case will be determined cancer positive if a pathological evaluation confirms a breast
cancer diagnosis (malignancy)
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. (If clinically indicated)
- Digital breast tomosynthesis (DBT), FDA Approved for breast screening and diagnosis,
various manufacturers.
- Handheld Ultrasound (HHUS), FDA-Cleared for diagnostic breast imaging, various
manufacturers. (If clinically indicated)
- Other diagnostic tests and medical device examinations of the breast, including, but not
limited to MRI, BSGI, PET, biopsy, and elastography, on the order of a licensed
physician, when clinically indicated.
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 1,000 total enrolled subjects
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
diagnostic evaluation or biopsy at multiple clinical sites.
- All participants will complete the same standard care diagnostic evaluations that were
recommended by a physician
- Eligible patients will receive a SV scan at the time of their scheduled diagnostic
appointments, preferably prior to biopsy
- Investigators at the sites will compare SV images to the accompanying diagnostic images
and pathology results
- No clinical SV interpretation will be performed and no clinical interventions will be
made or changed based on SV images
- All evaluation results, diagnosis and treatment outcomes will be recorded
- Cancer status for all participants will be surveyed from program entry until and
including the completion of physician recommended diagnostic workup
- A case will be determined cancer negative if the participant has non-malignant breast
biopsy findings or confirmed non-suspicious diagnostic breast imaging findings
- A case will be determined cancer positive if a pathological evaluation confirms a breast
cancer diagnosis (malignancy)
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
- Findings of concern on clinical breast exam or imaging
- Scheduled for diagnostic imaging, needle biopsy, excisional biopsy, or
post-needle-biopsy visit
- Diagnostic imaging assessment category BI-RADS 4 or 5 and willing to undergo
biopsy(ies) or, per the Principal Investigator, subject's case would be beneficial for
use in the lesion atlas or teaching library
- Agrees to be contacted by site staff if a recommended biopsy is not completed within
the appropriate time frame
Exclusion Criteria
- Unwilling/unable to comply with the protocol and follow-up recommendations
- Lumpectomy or excisional biopsy of the primary region of interest performed prior to
SoftVue imaging, such that there are not sufficient findings to make the case useful
for the lesion atlas or teaching library
- 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
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