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CTREP: Computed Tomography (CT) Reconstruction for Axillary Lymph Node Structure

Sponsor
Peking University (Other)
Overall Status
Completed
CT.gov ID
NCT03247478
Collaborator
(none)
160
Enrollment
1
Location
24.1
Actual Duration (Months)
6.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    160 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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
    Actual Study Start Date :
    Aug 25, 2017
    Actual Primary Completion Date :
    Jun 19, 2019
    Actual Study Completion Date :
    Aug 30, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    invasive breast cancer

    Patients with invasive breast cancer who underwent computed tomography (CT) reconstruction of axillary lymph node for assessment of lymph node response after NAC are eligible for this study. Axillary lymph node metastasis is confirmed by fine needle aspiration (FNA) or core needle biopsy (CNB) at initial diagnosis.

    Outcome Measures

    Primary Outcome Measures

    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. [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

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Peking University Cancer Hospital Beijing Beijing China 100142

    Sponsors and Collaborators

    • Peking University

    Investigators

    • Principal Investigator: Li-ze Wang, MD, Peking University Cancer Hospital & Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tao OUYANG, Director of Breast Center of Peking University Cancer Hospital, Peking University
    ClinicalTrials.gov Identifier:
    NCT03247478
    Other Study ID Numbers:
    • BCP20
    First Posted:
    Aug 11, 2017
    Last Update Posted:
    Sep 6, 2019
    Last Verified:
    Sep 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Tao OUYANG, Director of Breast Center of Peking University Cancer Hospital, Peking University
    Computed tomography (CT) reconstruction
    axillary lymph node status
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Sep 6, 2019