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NCT Number: NCT06775977

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Guangzhou, Guangdong, 510120, China

Location status: Recruiting

Location contact

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • (a) eligible patients should be 18-year-old or older;
  • (b) patients should have a histologically or cytologically confirmed diagnosis of primary bladder cancer;
  • (c) patients should not have had any surgery, chemotherapy, immunotherapy, or any therapy before CEUS diagnosis.

Exclusion criteria

  • (a) participants with confirmed to have no carcinoma of the bladder;
  • (b) participants with previous pelvic surgery, who had undergone therapy, any bladder surgery, or had received chemotherapy, radiotherapy or immunotherapy;
  • (c) participants diagnosed with tumor recurrence or metastasis; (d) participants who were allergic to ultrasound contrast agents or could not tolerate CEUS examination, for instance, with recent myocardial infarction, angina pectoris, cardiac insufficiency, severe cardiac arrhythmia, a right/left cardiac shunt, severe pulmonary hypertension, uncontrolled systemic hypertension, acute respiratory distress syndrome, or chronic obstructive pulmonary disease.

Treatment and study plan

contrast enhanced ultrasound (CEUS)

Diagnostic Test

Contrast Enhanced Ultrasound (CEUS) refers to the observation under ultrasound after the injection of ultrasound contrast agents, such as SonoVue or Lumason.

Primary outcomes

  1. Detection of Muscle Invasion in Bladder Cancer

    Time frame: within 3 minutes

    To evaluate the preoperative staging of bladder cancer,whether it is non-muscle invasive bladder cancer (NMIBC) or muscle invasive bladder cancers (MIBC)

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Other

Registry information

Official study title

Ultrasound Contrast-Enhanced Accurate Diagnosis of Preoperative Staging of Bladder Cancer: a Prospective, Observational Study

Acronym: UCEADP-BCS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 15, 2025
Registry last updated
Jan 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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