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NCT03247478 Clinical Trial

Computed Tomography (CT) Reconstruction for Axillary Lymph Node Structure

Invasive Breast Cancer Clinical Trial

— CTREP  

Official title:
Computed Tomography (CT) Reconstruction for Axillary Lymph Node Structure: a Prospective Observational Study Evaluating Response in Axillary Lymph Nodes of Breast Cancer After Neoadjuvant Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03247478
Other study ID # BCP20
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 25, 2017
Est. completion date August 30, 2019

Study information
Verified date September 2019
Source Peking University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 160
Est. completion date August 30, 2019
Est. primary completion date June 19, 2019
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
China Peking University Cancer Hospital Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sensitivity, specificity, positive-predictive value (PPV) and negative-predictive value (NPV) of Computed tomography (CT) reconstruction for axillary lymph node status after neoadjuvant chemotherapy. 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. within 6 weeks after obtaining the post-surgery pathological results
Secondary Rreceiver operating characteristic (ROC) curve analysis 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. within 6 weeks after obtaining the post-surgery pathological results
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