- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02977247
Delphinus SoftVue Prospective Case Collection - ARM 2 (SV PCC ARM2)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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. (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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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California
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Los Angeles, California, United States, 90033
- USC Keck School of Medicine
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Florida
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Miami Beach, Florida, United States, 33140
- Mount Sinai Medical Center
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Georgia
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Savannah, Georgia, United States, 31406
- SouthCoast Imaging
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Michigan
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Dearborn, Michigan, United States, 48124
- Beaumont Dearborn Breast Care Center
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Detroit, Michigan, United States, 48201
- Karmanos Cancer Institute
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Missouri
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Washington, Missouri, United States, 93090
- Mercy Imaging Services
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New York
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Rochester, New York, United States, 14620
- Elizabeth Wende Breast Care
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North Carolina
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Chapel Hill, North Carolina, United States, 27514
- UNC Breast Imaging Center
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15220
- Weinstein Imaging Associates
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Wisconsin
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Appleton, Wisconsin, United States, 54911
- Ascension St. Elizabeth, Radiology Associates of the Fox Valley
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Women undergoing routine diagnostic breast evaluation
Non-Interventional: Women presenting to enrollment sites for diagnostic examinations of symptoms or imaging findings, as recommended by a physician, and assigned BI-RADS category 4 or 5 (biopsy indicated).
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Only standard care procedures will be performed for clinical intervention and diagnostic purposes.
Other Names:
Bilateral breast ultrasound images will be captured, but not clinically evaluated for diagnostic purposes by a physician.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
No Breast Cancer
Time Frame: Current Diagnostic Evaluation Episode, 0 to 60 Days
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Non-Cancer cases, confirmed by normal or negative breast imaging findings or concordant breast biopsy with benign pathology.
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Current Diagnostic Evaluation Episode, 0 to 60 Days
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Breast Cancer
Time Frame: Current Diagnostic Evaluation Episode, 0 to 60 Days
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Cancer cases, confirmed by breast biopsy with malignant pathology
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Current Diagnostic Evaluation Episode, 0 to 60 Days
|
Collaborators and Investigators
Publications and helpful links
General Publications
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- Tabar 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.
- Swedish 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.
- Swedish 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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- Tabar 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.
- Michaelson 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.
- Smith 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.
- Kolb 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.
- Kerlikowske 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.
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- Cole EB, Pisano ED, Kistner EO, Muller KE, Brown ME, Feig SA, Jong RA, Maidment AD, Staiger MJ, Kuzmiak CM, Freimanis RI, Lesko N, Rosen EL, Walsh R, Williford M, Braeuning MP. Diagnostic accuracy of digital mammography in patients with dense breasts who underwent problem-solving mammography: effects of image processing and lesion type. Radiology. 2003 Jan;226(1):153-60. doi: 10.1148/radiol.2261012024.
- Haas BM, Kalra V, Geisel J, Raghu M, Durand M, Philpotts LE. Comparison of tomosynthesis plus digital mammography and digital mammography alone for breast cancer screening. Radiology. 2013 Dec;269(3):694-700. doi: 10.1148/radiol.13130307. Epub 2013 Oct 28.
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- Wolfe JN. Breast patterns as an index of risk for developing breast cancer. AJR Am J Roentgenol. 1976 Jun;126(6):1130-7. doi: 10.2214/ajr.126.6.1130.
- Ursin G, Hovanessian-Larsen L, Parisky YR, Pike MC, Wu AH. Greatly increased occurrence of breast cancers in areas of mammographically dense tissue. Breast Cancer Res. 2005;7(5):R605-8. doi: 10.1186/bcr1260. Epub 2005 Jun 8.
- Titus-Ernstoff L, Tosteson AN, Kasales C, Weiss J, Goodrich M, Hatch EE, Carney PA. Breast cancer risk factors in relation to breast density (United States). Cancer Causes Control. 2006 Dec;17(10):1281-90. doi: 10.1007/s10552-006-0071-1.
- Boyd NF, Guo H, Martin LJ, Sun L, Stone J, Fishell E, Jong RA, Hislop G, Chiarelli A, Minkin S, Yaffe MJ. Mammographic density and the risk and detection of breast cancer. N Engl J Med. 2007 Jan 18;356(3):227-36. doi: 10.1056/NEJMoa062790.
- Boyd NF, Martin LJ, Yaffe MJ, Minkin S. Mammographic density: a hormonally responsive risk factor for breast cancer. J Br Menopause Soc. 2006 Dec;12(4):186-93. doi: 10.1258/136218006779160436.
- Torres-Mejia G, De Stavola B, Allen DS, Perez-Gavilan JJ, Ferreira JM, Fentiman IS, Dos Santos Silva I. Mammographic features and subsequent risk of breast cancer: a comparison of qualitative and quantitative evaluations in the Guernsey prospective studies. Cancer Epidemiol Biomarkers Prev. 2005 May;14(5):1052-9. doi: 10.1158/1055-9965.EPI-04-0717.
- Stone J, Dite GS, Gunasekara A, English DR, McCredie MR, Giles GG, Cawson JN, Hegele RA, Chiarelli AM, Yaffe MJ, Boyd NF, Hopper JL. The heritability of mammographically dense and nondense breast tissue. Cancer Epidemiol Biomarkers Prev. 2006 Apr;15(4):612-7. doi: 10.1158/1055-9965.EPI-05-0127.
- Kolb TM, Lichy J, Newhouse JH. Occult cancer in women with dense breasts: detection with screening US--diagnostic yield and tumor characteristics. Radiology. 1998 Apr;207(1):191-9. doi: 10.1148/radiology.207.1.9530316.
- Checka CM, Chun JE, Schnabel FR, Lee J, Toth H. The relationship of mammographic density and age: implications for breast cancer screening. AJR Am J Roentgenol. 2012 Mar;198(3):W292-5. doi: 10.2214/AJR.10.6049.
- Sprague BL, Gangnon RE, Burt V, Trentham-Dietz A, Hampton JM, Wellman RD, Kerlikowske K, Miglioretti DL. Prevalence of mammographically dense breasts in the United States. J Natl Cancer Inst. 2014 Sep 12;106(10):dju255. doi: 10.1093/jnci/dju255. Print 2014 Oct.
- Rieber A, Brambs HJ, Gabelmann A, Heilmann V, Kreienberg R, Kuhn T. Breast MRI for monitoring response of primary breast cancer to neo-adjuvant chemotherapy. Eur Radiol. 2002 Jul;12(7):1711-9. doi: 10.1007/s00330-001-1233-x. Epub 2002 Feb 14.
- King V, Brooks JD, Bernstein JL, Reiner AS, Pike MC, Morris EA. Background parenchymal enhancement at breast MR imaging and breast cancer risk. Radiology. 2011 Jul;260(1):50-60. doi: 10.1148/radiol.11102156. Epub 2011 Apr 14.
- Saslow D, Boetes C, Burke W, Harms S, Leach MO, Lehman CD, Morris E, Pisano E, Schnall M, Sener S, Smith RA, Warner E, Yaffe M, Andrews KS, Russell CA; American Cancer Society Breast Cancer Advisory Group. American Cancer Society guidelines for breast screening with MRI as an adjunct to mammography. CA Cancer J Clin. 2007 Mar-Apr;57(2):75-89. doi: 10.3322/canjclin.57.2.75. Erratum In: CA Cancer J Clin. 2007 May-Jun;57(3):185.
- Kuhl CK, Schrading S, Strobel K, Schild HH, Hilgers RD, Bieling HB. Abbreviated breast magnetic resonance imaging (MRI): first postcontrast subtracted images and maximum-intensity projection-a novel approach to breast cancer screening with MRI. J Clin Oncol. 2014 Aug 1;32(22):2304-10. doi: 10.1200/JCO.2013.52.5386. Epub 2014 Jun 23.
- Corsetti V, Ferrari A, Ghirardi M, Bergonzini R, Bellarosa S, Angelini O, Bani C, Ciatto S. Role of ultrasonography in detecting mammographically occult breast carcinoma in women with dense breasts. Radiol Med. 2006 Apr;111(3):440-8. doi: 10.1007/s11547-006-0040-5. Epub 2006 Apr 11. English, Italian.
- Crystal P, Strano SD, Shcharynski S, Koretz MJ. Using sonography to screen women with mammographically dense breasts. AJR Am J Roentgenol. 2003 Jul;181(1):177-82. doi: 10.2214/ajr.181.1.1810177.
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Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- Breast Cancer
- Mammography
- Breast Carcinoma
- Breast Biopsy
- SoftVue
- Dense Breast Tissue
- Breast Screening
- Abnormal Breast
- Normal Breast
- Breast Imaging
- Tomosynthesis
- Automated Breast Ultrasound
- Breast Tumors
- Mammary Carcinoma
- Malignant Breast Tumor
- Mammary Neoplasm
- Mammary Cancer
- ABUS
- AWBUS
- Breast Tomography
- ATUS
- ABTUS
- Mammogram
- 3D Mammogram
- 3D ABUS
- 3D Breast Ultrasound
- DBT
- FFDM
- Digital Mammography
- Breast Ultrasound
- Dense Breasts
- Breast Density
- Dense Parenchyma
- Asymptomatic
- Delphinus
- Delphinus Medical Technologies
- Diagnostic Breast Imaging
Additional Relevant MeSH Terms
Other Study ID Numbers
- DMT-2015.001 ARM 2
- Protocol ID: 20151525 (OTHER: Western IRB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Regeneron PharmaceuticalsRecruitingHemophilia BUnited States, Germany, United Kingdom, Canada
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Henri Mondor University HospitalEuropean Society of Intensive Care MedicineRecruitingFournier Gangrene | Necrotizing Soft Tissue Infection | Necrotizing FasciitisFrance
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Medtronic Cardiac Rhythm and Heart FailureCompleted
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Respiratory Effectiveness GroupBoehringer IngelheimCompletedChronic Obstructive Pulmonary DiseaseKorea, Republic of, Singapore, Malta, Italy, Slovenia, Spain
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Eurasian Association of TherapistsCompletedCardiovascular Diseases | Pneumonia | Hypertension | Diabetes | Covid19 | Coronary Heart Disease | Copd | CKD | Overweight and Obesity | SARS-CoV-2 Infection | Cardiac EventRussian Federation