Computed Tomography (CT) Reconstruction for Axillary Lymph Node Structure

Completed

• Conditions: Invasive Breast Cancer

• Registration Number: NCT03247478
• Lead Sponsor: Peking University

Brief Summary

This is a prospective, single-center, non-randomized, non-controlled observational study.

Detailed Description

The negative predictive value of ultrasound for lymph node with neoadjuvant chemotherapy is low, magnetic resonance imaging (MRI) or PET/CT did not significantly improve specificity to axillary lymph node. The aim of this study is to determine performance of computed tomography (CT) reconstruction on evaluation of lymph node status after neoadjuvant chemotherapy in breast cancer patients.

Study Timeline

• Study First Submitted: 2017-08-09
• Study First Submitted QC: 2017-08-09
• Study First Posted: 2017-08-11
• Study Start: 2017-08-25
• Primary Completion: 2019-06-19
• Study Completion: 2019-08-30
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-04
• Last Update Posted: 2019-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 160

Inclusion Criteria

• Invasive breast cancer with axillary lymph node metastasis by confirmed by fine needle aspiration (FNA) or core needle biopsy (CNB).
• Underwent computed tomography (CT) reconstruction for assessment of axillary lymph node status before and after neoadjuvant chemotherapy (NAC).
• Attend the study voluntarily, sign the informed consent.

Exclusion Criteria

• Contradiction for adjuvant chemotherapy.
• Contradiction for proceeding surgery.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity, specificity, positive-predictive value (PPV) and negative-predictive value (NPV) of Computed tomography (CT) reconstruction for axillary lymph node status after neoadjuvant chemotherapy.	within 6 weeks after obtaining the post-surgery pathological results	Sensitivity, specificity, positive-predictive value (PPV) and negative-predictive value (NPV) of Computed tomography (CT) reconstruction for axillary lymph node status after neoadjuvant chemotherapy will be assessed.

Secondary Outcome Measures

Name	Time	Method
Rreceiver operating characteristic (ROC) curve analysis	within 6 weeks after obtaining the post-surgery pathological results	The diagnostic performance of computed tomography (CT) reconstruction for the evaluation of ALN after NAC was evaluated with receiver operating characteristic (ROC) curve analysis. The diagnostic accuracy was estimated by calculating the area under the ROC curve.

Trial Locations

Locations (1)

Peking University Cancer Hospital; 🇨🇳 Beijing, Beijing, China