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

NCT03470051 | Completed FDA Device

• 1 other identifier: BR007
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Breast Fibroadenoma

Outcome Measures

Primary Outcomes (1)

• Breast mass doubling time change

  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.

  90 days

Study Arms (2)

(2) QT Ultrasound scans prior to breast biopsy

Subjects will undergo a baseline QT scan, and a follow-up QT scan performed between 90 days and 180 days from their baseline QT Scan accompanied by a HHUS and ultrasound-guided breast biopsy following the first follow-up QT scan. BI-RADS will be confirmed by the radiologist at the time of the first HHUS. Subjects will receive a telephone follow-up contact approximately 2-3 business days after their ultrasound-guided breast biopsy to assess if any adverse events have occurred. Subjects will be asked to come back for an additional follow-up QT Scan 12 months from the time of their baseline QT Scan.

Diagnostic Test: QT Ultrasound

(0-1) QT Ultrasound scans prior to breast biopsy

Subjects that have not had (2) two QT Scans before their breast biopsy and who haven't yet had a breast biopsy will undergo an optional baseline QT scan accompanied by a HHUS and ultrasound-guided breast biopsy. BI-RADS will be confirmed by the radiologist. Subjects will receive a telephone follow-up contact approximately 2-3 business days after their ultrasound-guided breast biopsy to assess if any adverse events have occurred. Subjects will be asked to come back for a follow-up QT Scan between 90 and 180 days from the time of their study biopsy. Subjects that have had a breast biopsy on their identified breast mass(es) prior to study enrollment and have not already had two (2) QT Scans will undergo an optional baseline QT scan if between 0 and 30 days from their breast biopsy. Subjects will be asked to come back for a follow-up QT Scan 12 months from the time of their study biopsy.

Diagnostic Test: QT Ultrasound

Interventions

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.

(0-1) QT Ultrasound scans prior to breast biopsy; (2) QT Ultrasound scans prior to breast biopsy

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Subjects must be female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with a non-suspicious breast mass will be recruited.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• QT Ultrasound LLC: lead

Study Sites (2)

Memorial Care Long Beach

Long Beach, California, 90806, United States

Location

Marin Breast Health Trial Center

Novato, California, 94949, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Breast biopsy

MeSH Terms

Conditions

Fibroadenoma

Condition Hierarchy (Ancestors)

Neoplasms, Fibroepithelial; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial

Study Design

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

Study Record Dates

• First Submitted: March 12, 2018
• First Posted: March 19, 2018
• Study Start: February 26, 2018
• Primary Completion: February 11, 2020
• Study Completion: February 11, 2020
• Last Updated: March 18, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)