Multi-parameter Magnetic Resonance Imaging Guides Precise Treatment of Urothelial Carcinoma

  • STATUS
    Recruiting
  • End date
    Jun 26, 2026
  • participants needed
    100
  • sponsor
    The First Affiliated Hospital with Nanjing Medical University
Updated on 26 January 2021
radical cystectomy
carcinoma
lymphadenectomy
gemcitabine
invasive bladder cancer
transurethral resection
bladder tumor
transurethral bladder excision
recurrent bladder cancer

Summary

PurposeTo evaluate whether immediate multiparametric MRI evaluate the sensitivity of modified neoadjuvant chemotherapy early in patient with muscle invasive bladder cancerMIBC.

RationaleMultiparametric MRI may help detect the early changes of bladder cancer receiving neoadjuvant chemotherapy.

Description

Objective

Primary: To evaluate whether multiparametric MRI can determine the sensitivity of modified neoadjuvant chemotherapy early in patient with muscle invasive bladder cancerMIBC.

SecondaryTo determine whether multiparametric MRI can predict the prognosis of modified neoadjuvant chemotherapy early in patient with muscle invasive bladder cancer.

Patients may receive neoadjuvant chemotherapy (typically three 21-day courses of modified gemcitabine-cisplatin(GC) therapy) followed by radical cystectomy and lymph node dissection.

Patients with primary bladder cancer or recurrence which is confirmed by pathology of previous biopsy or TURBT, undergo a multiparametric MRI(mpMRI) at baseline to stage the primary tumor. The mpMRI includes T2-weighted MRI, diffusion-weighted imaging, and dynamic contrast enhancement, which will be given a five-point VI-RADSVesical Imaging-Reporting And Data System score by two radiologists specialized in urogenital radiology. Patients considered NMIBCNon-muscle invasive bladder cancer with mpMRI will be given TURBT, while patients with MIBCMuscle invasive bladder cancerwill receive radical cystectomy and lymph node dissection after three 21-day courses of modified gemcitabine-cisplatin neoadjuvant chemotherapy. Patients also undergo an immediate mpMRI scan after one, two, and three cycles of neoadjuvant chemotherapy.

Specimens from the radical cystectomy are then examined by the pathology department as standard routine.

Details
Condition urinary tract neoplasm, Urologic Cancer, bladder cancer, bladder cancer, Bladder Carcinoma, Urothelial Cancer, bladder disorder, Bladder Disorders, Urothelial Cancer, Bladder Disorders, Bladder Carcinoma, Urologic Cancer, carcinoma of the bladder, bladder tumor
Treatment Chemotherapy, Cystectomy and Lymphadenectomy, Immediate Multiparametric MRI, conventional Multiparametric MRI, Baseline Multiparametric MRI
Clinical Study IdentifierNCT04588168
SponsorThe First Affiliated Hospital with Nanjing Medical University
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Pathologically confirmed primary or recurrent bladder cancer
Planned to undergo transurethral resection of bladder tumor (TURBT) or modified GC regimen neoadjuvant chemotherapy plus radical total cystectomy
years old and older
Willing to give valid written informed consent
No contraindications to the MRI(magnetic resonance imaging) and MRI contrast agent

Exclusion Criteria

Abnormal liver function (1.5 times higher than normal)
Glomerular filtration rate < 60ml /minkg
Heart failure
Acute myocardial infarction
Severe heart and lung disease
Hypotension and hypoxia
Brain metastases, or other known central nervous system metastases
A history of severe central nervous system diseases, including unexplained loss of consciousness or transient ischemic attack
Known congenital or acquired immunodeficiency, active hepatitis, active tuberculosis and other active infections, etc
Pregnant or lactating women
Patients participating in other drug trials
Patients with poor general condition (eg malnutrition, dehydration). Behavioral status score (ZPS quintile) 2
Patients with previous autoimmune diseases or existing autoimmune diseases. (including controlled or uncontrolled drugs)
Patients undergoing organ transplantation (transplantation of liver, kidney, heart, lung and other organs) or those who require long-term administration of immunosuppressive agents due to personal conditions
Those who are intolerant or allergic to cytotoxic chemotherapeutic drugs
Bone marrow transplantation, severe leukopenia
Patients with severe infection or trauma
Any condition based on the investigation's clinical judgment that the patient is not suitable for completing this study (such as not meeting the patient's most beneficial treatment, patient compliance, etc.)
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