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Assessment of Periodic Screening of Women With Denser Breast Using WBUS and DBT (DBTUST)

Primary Purpose

Breast Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Whole breast ultrasound

About this trial

This is an interventional screening trial for Breast Cancer focused on measuring whole breast ultrasound, digital breast tomosynthesis, breast density, breast cancer screening

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Women aged 40 to 75 years of age with heterogeneously dense or extremely dense parenchyma by prior digital mammography report (i.e., "dense breasts"), presenting for routine annual mammography with digital breast tomosynthesis.

Exclusion Criteria:

Known to be at high risk for breast cancer due to known or suspected pathologic BRCA mutation (i.e. first-degree relative with known mutation) or prior chest radiation therapy before age 30;
No mammogram within the prior 3 years;
Signs or symptoms of breast disease including lump, bloody or spontaneous clear nipple discharge, eczema of the nipple;
Pregnancy or lactation within the prior 6 months;
Plan to become pregnant in the next two years, as mammography is not typically performed for screening pregnant women;
Breast implants, as assessment of breast density may be problematic;
Recent prior breast surgery or breast biopsy or cyst aspiration within the prior 12 months;
Prior or current malignancy other than the following: a) Breast cancer at least one year earlier (12 full months have elapsed since the last treatment surgery) with no known distant metastases and no known residual tumor; or b) Basal or squamous cell skin cancer or in situ cervical cancer or stage I thyroid cancer; or c) Other cancer for which the patient has been disease free for ≥ 5 years, with no recurrence of cancer in the last five years and no residual disease detected in the last five years.
Screening contrast-enhanced MRI or 99mTc-sestamibi based imaging of the breast(s) within the prior 12 months or planned within the next two years, to avoid contamination of results;
Unwilling or unable to provide consent.

Sites / Locations

Weinstein Imaging Associates
Magee-Womens Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Whole breast ultrasound

Arm Description

All women will receive both 3D mammography and whole breast ultrasound for breast cancer screening; the order of interpretation will vary for each of two radiologists

Outcomes

Primary Outcome Measures

Cancer Yield Per 1,000

Results from the first radiologist observer are presented

Sensitivity (True Positive Rate)

DBT true positive findings for first observer (usual care) vs DBT and WBUS true positive findings for first observer

False-positive Recall Rate

DBT false-positive findings for first observer (usual care) vs DBT and WBUS false positive findings for first observer

Secondary Outcome Measures

Types of Abnormalities Detected by Ultrasound and Tomosynthesis

Counts and percentages of participants diagnosed with cancer and detected by first observer with DBT only, DBT and WBUS, and WBUS only

Full Information

NCT ID

NCT02643966

First Posted

December 23, 2015

Last Updated

June 27, 2023

Sponsor

Wendie Berg

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT02643966

Brief Title

Assessment of Periodic Screening of Women With Denser Breast Using WBUS and DBT

Acronym

DBTUST

Official Title

Assessment of Periodic Screening of Women With Denser Breast Using WBUS and DBT (Also Known as "DBTUST-Dense Breast Tomosynthesis / Ultrasound Screening Trial")

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

December 2015 (undefined)

Primary Completion Date

May 2022 (Actual)

Study Completion Date

May 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Wendie Berg

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate the role of technologist-performed whole breast ultrasound for detecting breast cancer in the screening population of women with dense breasts.

Detailed Description

This is a prospective study designed to evaluate the role of whole breast ultrasound (WBUS) in screening for breast cancer. In particular, there is interest in investigating the value of using WBUS as an adjunct (supplementary imaging) to Digital Breast Tomosynthesis (DBT) based screening of women with dense (heterogeneously or extremely dense) breasts or as a primary screening examination in this group of women. Women scheduled for their routine mammography that includes a DBT exam who agree to participate in the study and sign informed consent will undergo (at the same visit) DBT imaging as part of their clinical exam and whole breast ultrasound (WBUS) each year for three rounds of screening plus one year of follow-up. The DBT images and WBUS will be interpreted independently by two experienced radiologists under standard clinical screening procedures. One radiologist will interpret the DBT and the other radiologist will interpret the WBUS. Using a modified "LOGICAL OR" approach women/subjects may be recalled for further diagnostic work-up (examinations). If a subject is recalled, she will then follow the standard/routine clinical procedures for follow-up and the investigators will verify outcomes. If neither radiologist recalls the subject, then the subject will follow conventional management and the investigators will verify outcome. The findings from the DBT and WBUS examinations, as well as any resulting follow-up, will be collected, recorded and analyzed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

whole breast ultrasound, digital breast tomosynthesis, breast density, breast cancer screening

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6266 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Whole breast ultrasound

Arm Type

Experimental

Arm Description

All women will receive both 3D mammography and whole breast ultrasound for breast cancer screening; the order of interpretation will vary for each of two radiologists

Intervention Type

Device

Intervention Name(s)

Whole breast ultrasound

Intervention Description

Breast cancer screening with whole breast ultrasound

Primary Outcome Measure Information:

Title

Cancer Yield Per 1,000

Description

Results from the first radiologist observer are presented

Time Frame

3 Years

Title

Sensitivity (True Positive Rate)

Description

DBT true positive findings for first observer (usual care) vs DBT and WBUS true positive findings for first observer

Time Frame

3 years

Title

False-positive Recall Rate

Description

DBT false-positive findings for first observer (usual care) vs DBT and WBUS false positive findings for first observer

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Types of Abnormalities Detected by Ultrasound and Tomosynthesis

Description

Counts and percentages of participants diagnosed with cancer and detected by first observer with DBT only, DBT and WBUS, and WBUS only

Time Frame

3 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Women aged 40 to 75 years of age with heterogeneously dense or extremely dense parenchyma by prior digital mammography report (i.e., "dense breasts"), presenting for routine annual mammography with digital breast tomosynthesis. Exclusion Criteria: Known to be at high risk for breast cancer due to known or suspected pathologic BRCA mutation (i.e. first-degree relative with known mutation) or prior chest radiation therapy before age 30; No mammogram within the prior 3 years; Signs or symptoms of breast disease including lump, bloody or spontaneous clear nipple discharge, eczema of the nipple; Pregnancy or lactation within the prior 6 months; Plan to become pregnant in the next two years, as mammography is not typically performed for screening pregnant women; Breast implants, as assessment of breast density may be problematic; Recent prior breast surgery or breast biopsy or cyst aspiration within the prior 12 months; Prior or current malignancy other than the following: a) Breast cancer at least one year earlier (12 full months have elapsed since the last treatment surgery) with no known distant metastases and no known residual tumor; or b) Basal or squamous cell skin cancer or in situ cervical cancer or stage I thyroid cancer; or c) Other cancer for which the patient has been disease free for ≥ 5 years, with no recurrence of cancer in the last five years and no residual disease detected in the last five years. Screening contrast-enhanced MRI or 99mTc-sestamibi based imaging of the breast(s) within the prior 12 months or planned within the next two years, to avoid contamination of results; Unwilling or unable to provide consent.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wendie Berg, MD, PhD

Organizational Affiliation

University of Pittsburgh

Official's Role

Principal Investigator

Facility Information:

Facility Name

Weinstein Imaging Associates

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15206

Country

United States

Facility Name

Magee-Womens Hospital

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Assessment of Periodic Screening of Women With Denser Breast Using WBUS and DBT

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