Diagnostic Performance of an Automated Breast Ultrasound System (ABUS)

NCT02661204 | Unknown

• 1 other identifier: BASEC 2015-00011
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the diagnostic performance of a new ABUS system among 4 different population: Population A: women undergoing screening for familial or genetic predisposition for breast cancer. Population B: women with newly diagnosed breast cancer. ABUS performance will be compared to breast MRI in the pre-operative assessment of breast cancer extent. Population C: women with BI-RADS 3 or 4 lesions in a routine breast imaging examination. ABUS will be evaluate as a problem-solving tool. Population D: women undergoing breast MRI for the assessment of breast implants integrity. ABUS performance will be compared to breast MRI.

Conditions

Breast Cancer; Implants

Outcome Measures

Primary Outcomes (4)

• Population A: comparison between ABUS and HHUS with respect to the number of lesions detected with the two devices and their characterization according to the BI-RADS lexicon

  5 years

• Population B:comparison between ABUS and breast MRI with respect to known malignant lesion/s size assessment and number of additional lesions detected and not previously evident with mammography and HHUS

  sensitivity and specificity of a new ABUS system in the assessment of breast cancer extent. Breast MRI will be used as standard of reference

  5 years

• Population C: number of patients with diagnosis of BI-RADS 3 and 4 breast lesions with ABUS compared to histological results or follow-up

  sensitivity and specificity of a new ABUS system in the assessment of BI-RADS 3 and 4 lesions. Follow-up and histological results of the biopsy or surgery will be used as standard of reference

  5 years

• Population D: number of participants with suspected rupture of breast implants diagnosed with ABUS compared to breast MRI diagnosis

  sensitivity and specificity of a new ABUS system in the assessment of breast implants integrity. Breast MRI will be used as standard of reference

  5 years

Study Arms (4)

Population A

Consecutive women in the age range 20 to 40 years, with a strong family history of breast cancer or a predisposing gene mutation such as BRCA1 or BRCA2, referring to our department for breast evaluation with ultrasound, will be invited to participate to the study. During the interview, before imaging examination, women will be questioned about family history as well as other relevant personal information (e.g. previous surgery or biopsy for benign breast disease).

Device: Automated breast ultrasound examination (ABUS)

Population B

Consecutive women with a new breast cancer diagnosis and undergoing pre-operative MRI examination for local staging will be invited to participate to the study. ABUS will be performed within two weeks before the scheduled surgery.

Device: Automated breast ultrasound examination (ABUS)

Population C

Consecutive women with BI-RADS 3 and 4 lesions detected in a routine breast imaging examination will be invited to participate to the study. ABUS will be performed just after the routine HH-US examination.

Device: Automated breast ultrasound examination (ABUS)

Population D

Consecutive women undergoing breast MRI examination for the evaluation of breast implants integrity will be invited to participate to the study. ABUS will be performed just after the breast MRI.

Device: Automated breast ultrasound examination (ABUS)

Interventions

Automated breast ultrasound examination (ABUS) DEVICE

Automated breast ultrasound examination

Population A; Population B; Population C; Population D

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Population A: women in the age range of 20 to 40 years, with a strong family history of breast cancer or a predisposing gene mutation such as BRCA1 or BRCA2. A total of 100 patients should be enrolled. Population B: women with new breast cancer diagnosis undergoing pre-operative local cancer staging.A total of 50 patients will be enrolled. Population C: women with lesions classified BI-RADS 3 or 4 in a routine breast imaging examination. A total of 50 patients will be enrolled. Population D: women undergoing breast-MRI for the evaluation of breast implants integrity. A total of 50 patients will be enrolled.

You may qualify if:

• Age between 20 and 40 years
• family history of breast cancer or a proved predisposing gene mutation such as BRCA1 or BRCA2
• Age ≥ 18 years
• Newly diagnosed breast cancer with no previous history of breast cancer
• Availability of pre-operative breast MRI performed for local staging within 4 weeks before the surgery
• Breast surgery performed at the UniversitätsSpital Zürich
• Age ≥ 18 years
• Newly detected BI-RADS 3 or 4 lesion
• Availability of follow-up examination or histological results of biopsy and surgery
• Age ≥ 18 years
• Availability of breast MRI performed for evaluating breast implants integrity

You may not qualify if:

• Personal history of breast or ovarian cancer

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich, Institute of Diagnostic and Interventional Radiology, University Hospital Zurich

Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Andreas Boss, MD

  University Hospital Zurich, Institute of Diagnostic and Interventional Radiology, University Hospital Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andreas Boss, MD

CONTACT

andreas.boss@usz.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2016
• First Posted: January 22, 2016
• Study Start: January 1, 2016
• Primary Completion: May 1, 2023
• Study Completion: October 1, 2023
• Last Updated: November 2, 2022

Record last verified: 2022-11

Locations

CH (1)