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

NCT04588168 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-10-19

No results posted yet for this study

Summary

Purpose：To evaluate whether immediate multiparametric MRI evaluate the sensitivity of modified neoadjuvant chemotherapy early in patient with muscle invasive bladder cancer（MIBC）.

Rationale：Multiparametric MRI may help detect the early changes of bladder cancer receiving neoadjuvant chemotherapy.

Conditions

Interventions

DRUG

Chemotherapy

Patients with muscle invasive bladder cancer will receive modified gemcitabine-cisplatin neoadjuvant chemotherapy prior to radical cystectomy for a period of two months (three 21 day cycles) as part of standard clinical routine.

DIAGNOSTIC_TEST

Immediate Multiparametric MRI

Within 24 hours after the use of cisplatin during the first course of modified GC neoadjuvant chemotherapy, patient considered muscle invasive bladder cancer with baseline mpMRI will receive an immediate mpMRI scan.

PROCEDURE

Cystectomy and Lymphadenectomy

The patient with muscle invasive bladder cancer will undergo radical cystectomy and pelvic lymph node dissection followed by a urinary tract reconstruction.

DIAGNOSTIC_TEST

conventional Multiparametric MRI

After two and three course of neoadjuvant chemotherapy, patient considered muscle invasive bladder cancer with baseline mpMRI will receive a conventional mpMRI scan.

DIAGNOSTIC_TEST

Baseline Multiparametric MRI

Patient considered muscle invasive bladder cancer will receive a baseline mpMRI scan within one week before neoadjuvant chemotherapy.

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Principal Investigators

  • Lv Qiang, MD，PHD · The First Affiliated Hospital with Nanjing Medical University

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04588168 on ClinicalTrials.gov