Computed Tomography (CT) Reconstruction for Axillary Lymph Node Structure

NCT ID: NCT03247478

Last Updated: 2019-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-25

Study Completion Date

2019-08-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Invasive Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Peking University

OTHER

Sponsor Role lead

Responsible Party

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Tao OUYANG

Director of Breast Center of Peking University Cancer Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Li-ze Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Locations

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Peking University Cancer Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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BCP20

Identifier Type: -

Identifier Source: org_study_id

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