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

• Sponsor: QT Ultrasound LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03470051
• Collaborator: (none)
• Enrollment: 27
• Locations: 2
• Actual Duration (Months): 23.5
• Patients Per Site: 13.5
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Breast Fibroadenoma	Diagnostic Test: QT Ultrasound

Study Design

• Study Type: Observational
• Actual Enrollment: 27 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official 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.
• Actual Study Start Date: Feb 26, 2018
• Actual Primary Completion Date: Feb 11, 2020
• Actual Study Completion Date: Feb 11, 2020

Arms and Interventions

Arm	Intervention/Treatment
(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; 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.	Diagnostic Test: 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.

Outcome Measures

Primary Outcome Measures

1. Breast mass doubling time change [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memorial Care Long Beach	Long Beach	California	United States	90806
2	Marin Breast Health Trial Center	Novato	California	United States	94949

Sponsors and Collaborators

• QT Ultrasound LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: QT Ultrasound LLC
• ClinicalTrials.gov Identifier: NCT03470051
• Other Study ID Numbers: BR007
• First Posted: Mar 19, 2018
• Last Update Posted: Mar 18, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Fibroadenoma

Study Results

No Results Posted as of Mar 18, 2021