Preoperative Detection of Muscle Invasion in Bladder Cancer with Contrast-enhanced Ultrasonography

Evaluation of the Preoperative Detection of Muscle Invasion in Bladder Cancer with Contrast-enhanced Ultrasonography: a Prospective Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05204108

Enrollment

1000

Registered

2022-01-24

Start date

2020-04-01

Completion date

2027-12-31

Last updated

2025-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer

Keywords

Bladder Cancer, Contrast-enhanced Ultrasonography

Brief summary

To evaluate the diagnostic accuracy of CEUS for the preoperative staging of bladder cancer, which would benefit the implementation of efficient therapeutic strategies.

Detailed description

Bladder cancer can be grouped into non-muscle invasive bladder cancer (NMIBC) and muscle invasive bladder cancers (MIBC), the latter displaying high aggressiveness, a high degree of malignancy, complicated treatment, high propensity to metastasis, and poor prognosis. Currently, the clinical feasibility and accuracy of preoperative detection of muscle invasion in bladder cancer with contrast-enhanced ultrasonography (CEUS) are unclear. To evaluate the diagnostic accuracy of CEUS for the preoperative staging of bladder cancer, which would benefit the implementation of efficient therapeutic strategies.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Detection of Muscle Invasion in Bladder Cancer	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)

Countries

China

Contacts

Primary ContactQiyun Ou, bachelor

ouqy5@mail.sysu.edu.cn020-34071020

Outcome results