The Application Value of Spectral CT in the Accurate Staging of Breast Cancer

NCT06977412 | Not Yet Recruiting

• 1 other identifier: KYLX2025-105
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

Spectral CT was used to prospectively collect medical images and clinical data related to breast cancer, evaluate the effect of image quality in the diagnosis of breast cancer, and evaluate the application value in the accurate staging of breast cancer, so as to provide a more accurate clinical basis for diagnosis, promote the development of individualized treatment, and ultimately improve the prognosis of patients.

Conditions

Breast Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Pathological TNM staging

  Pathological examination information: The pathology results using surgery/biopsy data are the gold standard, and the depth of tumor invasion, lymph node metastasis, and distant metastasis are recorded

  1 day

Study Arms (1)

The application value of spectral CT in the accurate staging of breast cancer

EXPERIMENTAL

Prospectively collect medical images and clinical data related to breast cancer using Philips Quark CT equipment, and evaluate the diagnostic accuracy and clinical application value in the accurate staging of breast cancer. Patients diagnosed with breast cancer in Yunnan Provincial Cancer Hospital from April 2025 to May 2026 were consecutively included, and after scanning with Philips Quark CT, the TNM stage of breast cancer patients was assessed by two radiologists, and finally statistical analysis was performed.

Diagnostic Test: To explore the value of spectral CT in the diagnosis and treatment of breast cancer

Interventions

To explore the value of spectral CT in the diagnosis and treatment of breast cancer DIAGNOSTIC_TEST

The CT scan is part of the standard treatment protocol.

The application value of spectral CT in the accurate staging of breast cancer

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (a) Chest quark energy spectrum CT examination was performed within 1 week before treatment
• (b) Age ≥ 18
• (c) Suspected breast cancer patients
• (d) Patients who signed informed consent

You may not qualify if:

• (a) Severe cardiac, pulmonary and renal insufficiency
• (b) Allergic to iodine contrast media
• (c) Unable to cooperate to complete CT examination
• (d) Quark spectrum CT image is poor and cannot be used
• (e) Male, pregnant and lactating female
• (f) Combined with other tumor history
• (g) Incomplete clinical and pathological data
• (h) Pathologically confirmed non breast cancer

Sponsors & Collaborators

• Yunnan Cancer Hospital: lead

Study Officials

• Lianhua Ye

  Ethics Committee of Yunnan Provincial Cancer Hospital

  STUDY DIRECTOR

Central Study Contacts

Caiyang Li

CONTACT

13658700171; 2020429049@kmmu.edu.cn

Zhenhui Li

CONTACT

13698736132; lizhenhui@kmmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: May 18, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: May 18, 2025

Record last verified: 2025-05