Multicenter study to evaluate the extent of breast cancer through the use of contrast-enhanced ultrasound (CE-US).

Multicenter study to evaluate the extent of breast cancer through the use of contrast-enhanced ultrasound (CE-US). - Evergreen Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000028995

Enrollment

140

Registered

2017-09-04

Start date

2017-06-27

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Operable breast cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients who had received breast surgery for breast cancer and whose diagnosois had been confirmed pathologically. 2. Pathological diagnosis was performed and tumor diameters data were available. 3. Pathological report included mapping of cancer sites. 4. Tumor diameter was measurable using B-mode and CEUS. 5. B-mode and CEUS were conducted in 3 months before breast surgery. 6. The maximum diameter was measured in approximately the same section for both B-mode and CEUS. 7. Perflubutane (Sonazoid) was used for CEUS. 8. Frozen flame and video images were both preserved in patient records.

Exclusion criteria

Exclusion criteria: 1. Prior breast surgery and radiation therapy. 2. Prior systemic therapy including chemotherapy, hormone therapy, and molecular target therapy in 3 months before registration.

Design outcomes

Primary

Measure	Time frame
The diameter obtained from the difference between the pathological investigation and the maximum diameter calculated using CEUS.	—

Secondary

Measure	Time frame
Secondary endpoint 1. The difference in mm between the tumor measured by CEUS and by pathological examination was obtained by measuring the difference between the pathological diameter and the maximum diameter calculated using B-mode. 2. The difference between the diameter found in B-mode compared to the pathological malignant diameter, and the difference in size between the diameter in CEUS measured against the pathological malignant diameter. 3. Pathological findings in the area where the lesion is detected by using CEUS rather than by B-mode. 4. Subgroup analysis for the difference between the pathological malignant diameter and B-mode/CEUS such as at the one-year post-diagnostic point, ER, HER2, lymphatic invasion and nuclear grade. 5. Analysis for the systemic error of length between CEUS/B-mode and pathological diameter. Exploratory endpoint 1. The difference of the maximum diameter in mm between the tumor measured by accumulated images and that found in default images in CEUS. 2. Pathological status (invasive, non-invasive, normal variation) of the parts, which were able to be observed by CEUS, but not B-mode.	—

Measure

Time frame

Secondary endpoint 1. The difference in mm between the tumor measured by CEUS and by pathological examination was obtained by measuring the difference between the pathological diameter and the maximum diameter calculated using B-mode. 2. The difference between the diameter found in B-mode compared to the pathological malignant diameter, and the difference in size between the diameter in CEUS measured against the pathological malignant diameter. 3. Pathological findings in the area where the lesion is detected by using CEUS rather than by B-mode. 4. Subgroup analysis for the difference between the pathological malignant diameter and B-mode/CEUS such as at the one-year post-diagnostic point, ER, HER2, lymphatic invasion and nuclear grade. 5. Analysis for the systemic error of length between CEUS/B-mode and pathological diameter. Exploratory endpoint 1. The difference of the maximum diameter in mm between the tumor measured by accumulated images and that found in default images in CEUS. 2. Pathological status (invasive, non-invasive, normal variation) of the parts, which were able to be observed by CEUS, but not B-mode.

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Countries

Japan

Contacts

Public ContactHiroaki Shima

Sapporo Medical University Department of Surgery, Surgical Oncology and Science

simahiro@sapmed.ac.jp+81-11-611-2111

Outcome results