Unique ID issued by UMIN | UMIN000028995 |
---|---|
Receipt number | R000030875 |
Scientific Title | Multicenter study to evaluate the extent of breast cancer through the use of contrast-enhanced ultrasound (CE-US). |
Date of disclosure of the study information | 2017/09/04 |
Last modified on | 2021/02/06 15:05:25 |
Multicenter study to evaluate the extent of breast cancer through the use of contrast-enhanced ultrasound (CE-US).
Evergreen Study
Multicenter study to evaluate the extent of breast cancer through the use of contrast-enhanced ultrasound (CE-US).
Evergreen Study
Japan |
Operable breast cancer
Breast surgery |
Malignancy
NO
This is a multicenter retrospective study designed to evaluate the deficiency of the maximum diameter of the tumor between in the pathological investigation and in the B-mode of ultrasound and contrast enhanced ultrasound (CEUS) individually. Moreover, this is also designed to analyze the findings in the area detected in not B-mode but CEUS.
Bio-equivalence
The diameter obtained from the difference between the pathological investigation and the maximum diameter calculated using CEUS.
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.
Observational
Not applicable |
Not applicable |
Male and Female
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.
1. Prior breast surgery and radiation therapy.
2. Prior systemic therapy including chemotherapy, hormone therapy, and molecular target therapy in 3 months before registration.
140
1st name | Hiroaki |
Middle name | |
Last name | Shima |
Sapporo Medical University
Department of Surgery, Surgical Oncology and Science
060-8543
S 1, W 16, Chuo-ku, Sapporo, 060-8543, Japan
+81-11-611-2111
simahiro@sapmed.ac.jp
1st name | Hiroaki |
Middle name | |
Last name | Shima |
Sapporo Medical University
Department of Surgery, Surgical Oncology and Science
060-8543
S 1, W 16, Chuo-ku, Sapporo, 060-8543, Japan
+81-11-611-2111
simahiro@sapmed.ac.jp
Department of Surgery, Surgical Oncology and Science, Sapporo Medical University
The Japan Association of Breast and Thyroid Sonology
Other
IRB
S1, W16, Chuo-ku, Sapporo
011-611-2111
simahiro@sapmed.ac.jp
NO
2017 | Year | 09 | Month | 04 | Day |
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000030875
Unpublished
https://doi.org/10.1007/s12282-020-01176-y
152
The mean widths as measured by the participating investigators were 15 +/- 7 mm (B-mode), 19 +/- 8 mm (CEUS), and 17+/-9 mm (P). The difference subtracted P from B-mode was - 3+/-7 mm (p<0.0001), and that from CEUS was 1+/-6 mm (p = 0.0163). The mean widths as measured by the independent reviewers were 16 +/- 7 mm (B-mode) and 18 +/- 7 mm (CEUS). The difference subtracted P from B-mode was - 2 +/- 8 mm (p = 0.0114), while that from CEUS was 1 +/- 7 mm (p = 0.1921).
2021 | Year | 02 | Month | 06 | Day |
The patient eligibility criteria were as follows: breast surgery following a pathological diagnosis, complete data regarding tumor width and surgical specimen mapping including documentation and photos, B-mode and CEUS imaging performed prior to breast surgery, and similar probe angles between the B-mode and CEUS images and the direction of pathological excision.
The median period for registered in each institution was 19 months (1-38 months) between August 2012 and January 2017 at 10 institutions in Japan. 912 patients were screened who had received B-mode/CEUS and breast surgery with primary breast cancer. The most common recruiting issue was the criteria that only those patients be included who had had similar plane B-mode and CEUS, with corresponding pathological findings in the same direction. Accordingly, 759 patients were excluded, and only 153 were enrolled. After excluding one patient in whom the tumor diameter exceeded the width of the transducer, a final total of 152 patient data sets were analyzed.
None.
The primary endpoint was a comparison of maximum tumor width measured by CEUS and that by P (CEUS-P). The secondary endpoint was a comparison of maximum tumor width measured by B-mode and that by P (B-mode-P). In an additional exploratory analysis, we investigated the presence of pathologically cancerous or non-cancerous lesions in areas that showed enhancement on CEUS (invisible in B-mode) but were not visualized outside the area of visible tumor on B-mode.
Completed
2017 | Year | 02 | Month | 10 | Day |
2017 | Year | 02 | Month | 10 | Day |
2017 | Year | 06 | Month | 27 | Day |
2019 | Year | 03 | Month | 31 | Day |
This study is being conducted as a research group of Japan Association of Breast and Thyroid Sonology (JABTS).
2017 | Year | 09 | Month | 04 | Day |
2021 | Year | 02 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030875
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |