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

NCT ID: NCT03470051

Last Updated: 2021-03-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 27 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-02-26
• Study Completion Date: 2020-02-11

Brief Summary

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

Conditions

Breast Fibroadenoma

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

(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.

QT Ultrasound

Intervention Type: 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

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.

QT Ultrasound

Intervention Type: 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.

Interventions

QT Ultrasound

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Female

2. Age 18 or older

3. Willing to receive QT Ultrasound Breast Scans

4. Willing to undergo an ultrasound-guided needle breast biopsy if performed after enrollment in the study

5. Willing and able to provide Informed Consent prior to any research-related procedure(s)

6. Have an identified solid non-suspicious breast mass

Exclusion Criteria

1. Pregnancy

2. Currently breastfeeding

3. 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.

4. Not willing to provide information for primary care physician

5. History of breast cancer

6. 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

7. Physical inability to tolerate the QT scan, i.e. inability to lie prone and still for up to 30 minutes at a time

8. Open wounds, sores or skin rash present on the breast(s) or nipple discharge from the scanned breast(s)

9. 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

10. Body weight greater than 400 lbs. (180 kg)

11. Concurrent disease or condition which in the judgment of the Principal Investigator disqualifies the subject from participating in the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

QT Ultrasound LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Memorial Care Long Beach

Long Beach, California, United States

Marin Breast Health Trial Center

Novato, California, United States

Countries

United States

Other Identifiers

BR007

Identifier Type: -

Identifier Source: org_study_id