Ignite Creation Date:
2024-05-06 @ 10:25 AM
Last Modification Date:
2024-10-26 @ 12:30 PM
Study NCT ID:
NCT03257839
Status:
COMPLETED
Last Update Posted:
2021-09-05
First Post:
2017-08-18
Brief Title:
Delphinus SoftVue Prospective Case Collection - ARM 1
Sponsor:
Delphinus Medical Technologies Inc
Organization:
Delphinus Medical Technologies Inc
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SV PCC ARM1
Brief 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 510k 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 transducers 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 17500 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 SVexams 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 SoftVueA subset of exams will be sampled from Arm 1 for use in ROC Reader Study protocol DMT-2015002 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
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 transducers 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 17500 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 SVexams 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 SoftVueA subset of exams will be sampled from Arm 1 for use in ROC Reader Study protocol DMT-2015002 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 510k 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 8122 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 17500 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 Incompleteand 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 eg 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 andor 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 510k 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 8122 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 17500 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 Incompleteand 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 eg 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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Protocol ID 20151525 | OTHER | Western IRB | None |