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Completed

NCT Number: NCT03470051

Case Collection Study in the Evaluation of Doubling Time Rates in Non-Suspicious Breast Masses Using QT Ultrasound Technology

This is a prospective case collection study to collect cases for subsequent statistical studies and future reader studies.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Memorial Care Long Beach, Long Beach, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female
  • Age 18 or older
  • Willing to receive QT Ultrasound Breast Scans
  • Willing to undergo an ultrasound-guided needle breast biopsy if performed after enrollment in the study
  • Willing and able to provide Informed Consent prior to any research-related procedure(s)
  • Have an identified solid non-suspicious breast mass

Exclusion criteria

  • Pregnancy
  • Currently breastfeeding
  • Magnetic material in the chest which in the judgement of the Principal Investigator would interfere or be impacted by the magnets utilized with the study device.
  • Not willing to provide information for primary care physician
  • History of breast cancer
  • History of treated or untreated cancer of a non-breast origin which in the judgment of the Principal Investigator would be a concern for metastatic disease to the breast
  • Physical inability to tolerate the QT scan, 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(s)
  • 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)
  • Concurrent disease or condition which in the judgment of the Principal Investigator disqualifies the subject from participating in the study

Treatment and study plan

QT Ultrasound

Diagnostic Test

All subjects will be asked to agree to an ultrasound-guided breast needle biopsy by a qualified radiologist experienced in this procedure if not already completed prior to study entry.

Primary outcomes

  1. Breast mass doubling time change

    Time frame: 90 days

    The change in calculated mass doubling time using Quantitative Transmission Ultrasound (QT Ultrasound) from a minimum of two study timepoints will be measured and compared to mass histology.

Sponsors and collaborators

Lead sponsor

QT Ultrasound LLC

Industry

Registry information

Official study title

A Prospective Multi-center Case Collection Study of Breast Imaging Examinations From Women With Non-suspicious Breast Masses to Correlate the Calculated Mass Doubling Time Using Quantitative Transmission Ultrasound (QT Ultrasound) With Mass Histology.

Acronym: EVALUATE

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 19, 2018
Registry last updated
Mar 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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