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JOURNAL ONKOLOGIE – STUDIE

Diagnostic Performance of an Automated Breast Ultrasound System (ABUS)

Rekrutierend

NCT-Nummer:
NCT02661204

Studienbeginn:
Januar 2016

Letztes Update:
02.11.2022

Wirkstoff:
-

Geschlecht:
Frauen

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University of Zurich

Collaborator:
-

Studienleiter

Andreas Boss, MD
Principal Investigator
University Hospital Zurich, Institute of Diagnostic and Interventional Radiology, University Hospital Zurich

Kontakt

Studienlocations
(1 von 1)

University Hospital Zurich, Institute of Diagnostic and Interventional Radiology, University Hospital Zurich
8091 Zurich
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Andreas Boss, MD
Phone: +41442553677
E-Mail: andreas.boss@usz.ch
» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. 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 (Time Frame - 5 years)

2. 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 (Time Frame - 5 years):
sensitivity and specificity of a new ABUS system in the assessment of breast cancer extent. Breast MRI will be used as standard of reference

3. Population C: number of patients with diagnosis of BI-RADS 3 and 4 breast lesions with ABUS compared to histological results or follow-up (Time Frame - 5 years):
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

4. Population D: number of participants with suspected rupture of breast implants diagnosed with ABUS compared to breast MRI diagnosis (Time Frame - 5 years):
sensitivity and specificity of a new ABUS system in the assessment of breast implants integrity. Breast MRI will be used as standard of reference

Studien-Arme

  • 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).
  • 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.
  • 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.
  • 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.

Geprüfte Regime

  • Automated breast ultrasound examination (ABUS):
    Automated breast ultrasound examination

Quelle: ClinicalTrials.gov


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