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CompletedNCT03247478CTREPUpdated Sep 6, 2019

Computed Tomography (CT) Reconstruction for Axillary Lymph Node Structure

An observational study in Invasive Breast Cancer, sponsored by Peking University. Completed at 1 site in China. Open to female participants. Per ClinicalTrials.gov, last updated 2019-09-06.

Sponsored by Peking University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
160
Sex
Female
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Study summary

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

Read the 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.

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Conditions studied

  • Invasive Breast Cancer

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Keywords

  • Computed tomography (CT) reconstruction
  • axillary lymph node status
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In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 160 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

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Lead sponsor

Peking University is the lead sponsor of 411 studies on the registry; 122 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Invasive breast cancer with axillary lymph node metastasis: stage N1-2.

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
160 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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.

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What researchers measure

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.

    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.

    Time frame: within 6 weeks after obtaining the post-surgery pathological results

Secondary outcomes

  1. 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.

    Time frame: within 6 weeks after obtaining the post-surgery pathological results

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Study locations

1 site
  • Peking University Cancer Hospital
    Beijing, Beijing 100142, China
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 6, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03247478
Lead sponsor
Peking University
Responsible party
Tao OUYANG (Director of Breast Center of Peking University Cancer Hospital, Peking University) — Principal investigator
First posted
Aug 11, 2017
Start date
Aug 25, 2017
Primary completion
Jun 19, 2019
Completion
Aug 30, 2019
Last update
Sep 6, 2019

Study contacts

Li-ze Wang, MD
principal investigator · Peking University Cancer Hospital & Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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