Ultrasound Contrast-Enhanced Accurate Diagnosis of Preoperative Staging of Bladder Cancer

Last updated: January 21, 2025
Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Bladder Cancer

Urothelial Carcinoma

Urothelial Cancer

Treatment

Contrast Enhanced Ultrasound (CEUS)

Clinical Study ID

NCT06775977
SYSKY-2024-145-01
Grant No.2023CSM003
  • Ages 18-75
  • All Genders

Study Summary

Ultrasound and magnetic resonance imaging (MRI) technologies have become essential tools for the diagnosis and preoperative staging assessment of bladder cancer. However, establishing a precise system suitable for clinical application remains a significant challenge, and accurate prediction of bladder cancer staging is not yet possible. Therefore, exploring a system for the precise diagnosis of preoperative staging of bladder cancer using ultrasound contrast enhancement or a combination of ultrasound contrast enhancement and MRI is of great importance. The applicant has previously demonstrated the accuracy of multimodal data analysis in the diagnosis and prediction of malignant tumors. Preliminary results from this study have shown that ultrasound contrast enhancement has a high diagnostic efficacy for the preoperative staging assessment of bladder cancer, with a high area under the curve (AUC) of 0.88, sensitivity of 83.3%, specificity of 92.5%, and accuracy of 90.8%. In this project, the applicant intends to further expand the sample size and, based on the combination of ultrasound contrast enhancement and MRI, develop a precise diagnostic system for the preoperative staging of bladder cancer to aid clinical treatment decisions.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • (a) eligible patients should be 18-year-old or older;

  • (b) patients should have a histologically or cytologically confirmed diagnosis ofprimary bladder cancer;

  • (c) patients should not have had any surgery, chemotherapy, immunotherapy, or anytherapy before CEUS diagnosis.

Exclusion

Exclusion Criteria:

  • (a) participants with confirmed to have no carcinoma of the bladder;

  • (b) participants with previous pelvic surgery, who had undergone therapy, anybladder surgery, or had received chemotherapy, radiotherapy or immunotherapy;

  • (c) participants diagnosed with tumor recurrence or metastasis; (d) participants whowere allergic to ultrasound contrast agents or could not tolerate CEUS examination,for instance, with recent myocardial infarction, angina pectoris, cardiacinsufficiency, severe cardiac arrhythmia, a right/left cardiac shunt, severepulmonary hypertension, uncontrolled systemic hypertension, acute respiratorydistress syndrome, or chronic obstructive pulmonary disease.

Study Design

Total Participants: 480
Treatment Group(s): 1
Primary Treatment: Contrast Enhanced Ultrasound (CEUS)
Phase:
Study Start date:
January 01, 2024
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong 510120
    China

    Active - Recruiting

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