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Completed

NCT Number: NCT03247478

Computed Tomography (CT) Reconstruction for Axillary Lymph Node Structure

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

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Key information

Conditions

Invasive Breast Cancer

Sex eligibility

Female

Study type

Observational

Primary location

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100142, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Sensitivity, specificity, positive-predictive value (PPV) and negative-predictive value (NPV) of Computed tomography (CT) reconstruction for axillary lymph node status after neoadjuvant chemotherapy.

    Time frame: 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 outcomes

  1. Rreceiver operating characteristic (ROC) curve analysis

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Peking University

Other

Registry information

Official study 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

Acronym: CTREP

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 11, 2017
Registry last updated
Sep 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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