A Predictive Model for Breast Cancer

Sponsor

First Affiliated Hospital Xi'an Jiaotong University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05826197

Collaborator

(none)

100

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Patients with suspected breast cancer undergoing PET/CT at our hospital. The PET/CT center's chief physician and senior attending physician reviewed the films together and disagreement, if any, was resolved by consensus. The lesion was visually identified. A 3D region of interest(ROI) of the lesion was automatically outlined using the 40% threshold method, and PET metabolic parameters were measured . Breast lesions with radionuclide concentrations greater than those in normal breast tissue are considered to be breast cancer lesions, while lymph nodes with radionuclide concentrations greater than those in muscle tissue are considered to be metastatic lymph nodes.

Image segmentation: Image segmentation was performed using ITK-SNAP software (4) (version 3.6.0, http://www.itksnap.org/), Brush Style: circular, Brush Size: 10, Brush Options: 3D. The entire tumor volume was outlined on the PET image as ROI for segmentation.

An open source Python package (PyRadiomics version 3.0.1(5)) was used to extract the radiomics features from the ROI.

Univariate and multivariate binary logistic regressions were used to construct model for predicting lymph node metastasis in breast cancer.

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasms	Other: Radiomics

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

A Study on the Construction of a Comprehensive Predictive Model for Axillary Lymph Node Metastasis in Breast Cancer

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Axillary lymph node metastasis	Other: Radiomics PET Radiomics
No axillary lymph node metastasis

Arm

Intervention/Treatment

Axillary lymph node metastasis

Other: Radiomics

PET Radiomics

No axillary lymph node metastasis

Outcome Measures

Primary Outcome Measures

Radiomics score [1 day During the inspection]
Radiomics score

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

Female

Inclusion Criteria:

1. 18F-FDG PET/CT for breast occupancy; 2) adult female patients with pathologically confirmed breast cancer (age ≥18 years); 3) no history of surgery, radiotherapy, or chemotherapy before 18F-FDG PET/CT; and 4) interval between 18F-FDG PET/CT and puncture/surgery ≤2 weeks.

Exclusion Criteria:

1. multifocal, bilateral, or occult breast cancer; 2) incomplete clinical or pathological data; 3) poor PET/CT image quality, when metabolic tumor volume(MTV) cannot be automatically segmented; and 4) concomitant malignant tumors.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

First Affiliated Hospital Xi'an Jiaotong University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

First Affiliated Hospital Xi'an Jiaotong University

ClinicalTrials.gov Identifier:

NCT05826197

Other Study ID Numbers:

2023-YBSF-480

First Posted:

Apr 24, 2023

Last Update Posted:

Apr 24, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Breast Neoplasms

Study Results

No Results Posted as of Apr 24, 2023