Assessment of Automated Breast Ultrasound

NCT02386176 | Completed

• 1 other identifier: PRO14110472
• Study Type: observational
• Target: 598
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators are interested in assessing the value of and comparing the use of automated breast ultrasound (ABUS) (either as a primary screening approach or as a supplementary procedure) with digital breast tomosynthesis (DBT). The purpose of this project is to perform a preliminary prospective study on women who are most likely to benefit from the use of ABUS and/or DBT (or a combination of both) in the screening environment.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• false positive rates

  from the date interpretation until the date routine follow-up, biopsy results, or pathology results, whichever comes first, up to 24 months.

Eligibility Criteria

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

Study Population

Women aged 40 to 75 years of age with a defined region of extremely dense breast tissue or 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 qualify if:

• to 75 years of age with a
• defined region of extremely dense breast tissue or 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 breast cancer susceptibility gene (BRCA) (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 at the time of screening by self report or lactation within the prior 6 months;
• 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;
• Had prior screening with DBT and not a hand held ABUS, or had prior screening with ABUS and not DBT.
• Prior malignancy other than: 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 Basal or squamous cell skin cancer or in situ cervical cancer, or 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
• Unwilling or unable to provide consent.

Sponsors & Collaborators

• University of Pittsburgh: lead
• GE Healthcare: collaborator

Study Sites (1)

Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Denise M Chough, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 5, 2015
• First Posted: March 11, 2015
• Study Start: August 1, 2015
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: April 6, 2020

Record last verified: 2020-04

Locations

US (1)