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

NCT02643966 | Completed Results

• 2 other identifiers: PRO14100275R01CA187593-01A1
• Study Type: interventional
• Target: 6,266
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Cancer Yield Per 1,000

  Results from the first radiologist observer are presented

  3 Years

• Sensitivity (True Positive Rate)

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

  3 years

• False-positive Recall Rate

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

  3 years

Secondary Outcomes (1)

• Types of Abnormalities Detected by Ultrasound and Tomosynthesis

  3 years

Study Arms (1)

Whole breast ultrasound

EXPERIMENTAL

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

Device: Whole breast ultrasound

Interventions

Whole breast ultrasound DEVICE

Breast cancer screening with whole breast ultrasound

Whole breast ultrasound

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wendie Berg: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Weinstein Imaging Associates

Pittsburgh, Pennsylvania, 15206, United States

Location

Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• Berg WA, Zuley ML, Chang TS, Gizienski TA, Chough DM, Bohm-Velez M, Sharek DE, Straka MR, Hakim CM, Hartman JY, Harnist KS, Tyma CS, Kelly AE, Waheed U, Houshmand G, Nair BE, Shinde DD, Lu AH, Bandos AI, Berg JM, Lettiere NB, Ganott MA. Prospective Multicenter Diagnostic Performance of Technologist-Performed Screening Breast Ultrasound After Tomosynthesis in Women With Dense Breasts (the DBTUST). J Clin Oncol. 2023 May 1;41(13):2403-2415. doi: 10.1200/JCO.22.01445. Epub 2023 Jan 10.

  PMID: 36626696 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr. Wendie A. Berg
• Organization: University of Pittsburgh

bergwa@upmc.edu

412-641-1635

Study Officials

• Wendie Berg, MD, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Radiology

Study Record Dates

• First Submitted: December 23, 2015
• First Posted: December 31, 2015
• Study Start: December 1, 2015
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: June 29, 2023
• Results First Posted: June 29, 2023

Record last verified: 2023-06

Locations

US (2)