Computed Tomography (CT) Reconstruction for Axillary Lymph Node Structure

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03247478

Acronym

CTREP

Enrollment

160

Registered

2017-08-11

Start date

2017-08-25

Completion date

2019-08-30

Last updated

2019-09-06

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

Conditions

Invasive Breast Cancer

Keywords

Computed tomography (CT) reconstruction, axillary lymph node status

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

China

Outcome results