Breast Cancer Clinical Trial
Official title:
Precision Breast Conserving Surgery With the Guidance of Localization Combined With Multidetector CT 3-dimensional Image Reconstruction: a Single Center, Prospective, Cohort Study.
NCT number | NCT05708664 |
Other study ID # | PBCST |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 1, 2021 |
Est. completion date | January 1, 2023 |
Verified date | January 2023 |
Source | The First Affiliated Hospital with Nanjing Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
From 2021 to 2022, 31 patients with unifocal breast cancer were enrolled for precision breast conserving surgery (PBCS) guided by wire guided localization (WGL) combined with CT guided 3D reconstruction. Surrounded WGL was performed under local anesthesia, followed by an immediate contrast enhanced CT scan. PBCS guided by CT guided 3D reconstruction was performed one day after the localization. Women who underwent palpation guided breast conserving surgery (BCS) were included as control. Two-sided Student t test, Fisher's exact test and chi-square test was applied.
Status | Completed |
Enrollment | 92 |
Est. completion date | January 1, 2023 |
Est. primary completion date | June 30, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - women with T1/T2 invasive breast cancer confirmed by core biopsy - be suitable for BCS - the tumor should be unilateral and unifocal which is clearly visible with US Exclusion Criteria: - patients with an extensive intraductal component in invasive cancer - patients who were pregnant or breast-feeding - patients receiving neoadjuvant therapies. |
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hospital with Nanjing Medical University | Nanjing | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
The First Affiliated Hospital with Nanjing Medical University |
China,
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Li P, Li L, Xiu B, Zhang L, Yang B, Chi Y, Xue J, Wu J. The Prognoses of Young Women With Breast Cancer (</=35 years) With Different Surgical Options: A Propensity Score Matching Retrospective Cohort Study. Front Oncol. 2022 Feb 28;12:795023. doi: 10.3389/fonc.2022.795023. eCollection 2022. — View Citation
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* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The sum of located margin resection widths | The sum of the resection widths of located superior, inferior, lateral and interior margins | 1 month post operation | |
Secondary | The specimen diameter | The diameter of the breast specimen was measured by pathologists | 1 month post operation | |
Secondary | the largest margin resection width | the largest resection width of the located superior, inferior, lateral and interior margins | 1 month post operation | |
Secondary | Operation time | the duration of the surgery | intraoperative | |
Secondary | Patients reported outcomes | Breast Cancer Treatment Outcome Scale (BCTOS) cosmetic subscale was used to access patient reported cosmetic outcomes in our study. | participants completed the scale at baseline (before surgery), 1 month post operation and 6 months post radiotherapy (RT) |
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