Non-Inferiority Quantitative Transmission Ultrasound Case Collection Study

NCT02133417 | Completed

• 1 other identifier: 2013001
• Study Type: observational
• Target: 287
• Locations: 1 country
• Sites: 2

Brief Summary

Conduct a case collection study of breast imaging examinations from women with mammographically-detected breast lesions for the purpose of conducting subsequent Reader Studies.

Conditions

Mass Lesion

Keywords

Quantitative Transmission Ultrasound; QTUS

Outcome Measures

Primary Outcomes (1)

• The purpose of the case collection study is to collect mammographically-detected breast lesions seen in at least one mammographic view in the clinical setting and seen on HHUS, and confirmed by pathology.

  This is a prospective Case Collection study for the purpose of conducting subsequent Reader Studies. The primary objective for this prospective case collection study is to provide up to 300 cytology/pathology confirmed cases for subsequent Reader Studies.

  12 months

Study Arms (1)

Women

Women with mammographically-detected breast lesions

Device: Quantitative Transmission Ultrasound

Interventions

Quantitative Transmission Ultrasound DEVICE

Quantitative Transmission Ultrasound (QTUS) as an automated breast ultrasound procedure for women who have a mammographically detected mass.

Also known as: QTUS, QT Ultrasound

Women

Eligibility Criteria

• Age: 25 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Eligibility for enrollment will be open to women of all races and ethnicities who have completed a diagnostic XRM with a mammographically-detected lesion(s) in at least one mammographic view and have a lesion seen on HHUS corresponding to the XRM lesion(s). Women with a normal mammogram at the time of this evaluation are not eligible to participate. Women younger than 25 years of age will not be eligible to participate. Potential subjects must not be breastfeeding at the time of diagnostic breast imaging. Patients who have had breast cancer, breast surgeries, or interventional breast procedures in the past 12 months will not be eligible to enter the study.

You may qualify if:

• Female
• Age 25 or older
• A bra cup size of A through DDD
• Willing and able to provide written, signed Informed Consent Form (ICF) after the nature of the study has been explained, all questions have been answered, and prior to any research-related procedure(s)
• Willing and able to comply with all study procedure(s), including possible aspiration for a simple cyst
• Complete digital mammography views Craniocaudal and Medio-lateral Oblique (CC and MLO) for one or both breasts
• Mammographically-detected lesion(s) seen on at least one mammographic view and a corresponding HHUS correlate(s)

You may not qualify if:

• Currently breastfeeding
• History of breast cancer in the past 12 months, except for Fine Needle Aspirations (FNA) or Cyst Aspiration
• History of breast surgeries or interventional breast procedures in the past 12 months
• Normal mammogram at the time of this evaluation
• Physical inability to tolerate the procedure on the scanner, i.e. inability to lie prone and still for up to 30 minutes at a time
• Open wounds, sores or skin rash present on the breast(s) or nipple discharge from the scanned breast
• Breasts too large for scanner, i.e. bra size larger than DDD or inability to successfully "fit" breast after the subject is placed on scanner
• Body weight greater than 400 lbs. (180 kg)
• Has a concurrent disease or condition which in the judgment of the principal investigator disqualifies the subject, from participating in the study

Sponsors & Collaborators

• QT Ultrasound LLC: lead

Study Sites (2)

George Washington University Medical Center

Washington D.C., District of Columbia, 20037, United States

Location

Elizabeth Wende Breast Care, LLC

Rochester, New York, 14620, United States

Location

Study Officials

• Rajni Natesan, MD

  Chief Medical Officer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2014
• First Posted: May 8, 2014
• Study Start: July 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: May 9, 2018

Record last verified: 2018-05

Locations

US (2)