Clinical trial NCT02661204: Diagnostic Performance of an Automated Breast Ultrasound System (ABUS)
Official title: Diagnostic Performance of an Automated Breast Ultrasound System (ABUS): a Single Centre Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Implants
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2016-01-22
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: 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.

The expected duration of subject participation is 5 years for population A: every year the patients will undergo ABUS examination and the results will be compared with HHUS examination.

In population B, C and D only one examination will be performed and the data obtained with ABUS will be compared with HH-US and breast MRI data.

Images will be evaluated by a radiologist with breast imaging experience and ABUS findings will be compared with findings from HHUS and MR imaging.

Afterwards, two or three readers (radiologists with different levels of experience in breast imaging) blinded to clinical, HH-US and MRI data, will evaluate the interobserver agreement ABUS images will be evaluated by Methods of minimising bias Population A - During the recruitment, family history of breast cancer will be in-depth analysed in order to avoid the bias related to different levels of risk for breast cancer. In order to reduce the loss of patients to follow-up, women will be invited every year to undergo HHUS and ABUS examination at our department.

Eligibility criteria: Inclusion Criteria:

1. Population A - Inclusion criteria:

   * Age between 20 and 40 years
   * family history of breast cancer or a proved predisposing gene mutation such as BRCA1 or BRCA2
2. Population B - Inclusion criteria

   * 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
3. Population C - Inclusion criteria

   * Age ≥ 18 years
   * Newly detected BI-RADS 3 or 4 lesion
   * Availability of follow-up examination or histological results of biopsy and surgery
4. Population D - Inclusion criteria

   * Age ≥ 18 years
   * Availability of breast MRI performed for evaluating breast implants integrity

Exclusion Criteria:

1) Population A - Exclusion criteria:

* Personal history of breast or ovarian cancer

Primary outcomes:
measure: 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
timeFrame: 5 years
measure: 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
timeFrame: 5 years
measure: Population C: number of patients with diagnosis of BI-RADS 3 and 4 breast lesions with ABUS compared to histological results or follow-up
timeFrame: 5 years
measure: Population D: number of participants with suspected rupture of breast implants diagnosed with ABUS compared to breast MRI diagnosis
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Institute of Diagnostic and Interventional Radiology, University Hospital Zurich
Study officials:
affiliation: University Hospital Zurich, Institute of Diagnostic and Interventional Radiology, University Hospital Zurich
name: Andreas Boss, MD
role: PRINCIPAL_INVESTIGATOR
References: