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

October 8, 2020 updated by: The First Affiliated Hospital with Nanjing Medical University

Multi-parameter Magnetic Resonance Imaging for Early Evaluation of the Efficacy of Neoadjuvant Chemotherapy With Modified GC Regimen for Urothelial Carcinoma

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Objective

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

Secondary：To 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-RADS（Vesical Imaging-Reporting And Data System） score by two radiologists specialized in urogenital radiology. Patients considered NMIBC（Non-muscle invasive bladder cancer） with mpMRI will be given TURBT, while patients with MIBC（Muscle invasive bladder cancer）will 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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Recruiting
        • The First Affiliated Hospital of Nanjing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.
  • 18 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 /min·kg.
  • 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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: Chemotherapy + mpMRI + surgery

Baseline mpMRI /Neoadjuvant chemotherapy /Immediate mpMRI /Cystectomy and Lymphadenectomy / Postoperative pathology

Drug: Chemotherapy Procedure: Immediate Multiparametric MRI Procedure: Cystectomy and Lymphadenectomy
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.
Other Names:
  • Neoadjuvant chemotherapy
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.
Other Names:
  • Multiparameter magnetic resonance imaging
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.
Other Names:
  • surgery
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.
Other Names:
  • Multiparameter magnetic resonance imaging
Diagnostic test: Baseline Multiparametric MRI
Patient considered muscle invasive bladder cancer will receive a baseline mpMRI scan within one week before neoadjuvant chemotherapy.
Other Names:
  • Multiparameter magnetic resonance imaging
Experimental: Experimental: Chemotherapy + surgery

Baseline mpMRI /Neoadjuvant chemotherapy /Cystectomy and Lymphadenectomy / Postoperative pathology

Drug: Chemotherapy Procedure: Cystectomy and Lymphadenectomy
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.
Other Names:
  • Neoadjuvant chemotherapy
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.
Other Names:
  • surgery
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.
Other Names:
  • Multiparameter magnetic resonance imaging
Diagnostic test: Baseline Multiparametric MRI
Patient considered muscle invasive bladder cancer will receive a baseline mpMRI scan within one week before neoadjuvant chemotherapy.
Other Names:
  • Multiparameter magnetic resonance imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes from baseline tumor mp-MRI parameters at immediate mp-MRI evaluation.
Time Frame: baseline, during the intervention (Within 24 hours after use of cisplatin of the first course of neoadjuvant chemotherapy(NAC), up to 2 weeks)
Using the built-in tools of the MRI imaging system to assess the changes of tumor size between immediate mp-MRI evaluation and baseline mp-MRI evaluation after the use of cisplatin during the first course of modified GC neoadjuvant chemotherapy.
baseline, during the intervention (Within 24 hours after use of cisplatin of the first course of neoadjuvant chemotherapy(NAC), up to 2 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes from baseline tumor mp-MRI parameters after two course of modified GC neoadjuvant chemotherapy.
Time Frame: baseline, during the intervention(From the end date of the second course of NAC until one day before the third course of NAC, up to 7 weeks)
Using the built-in tools of the MRI imaging system to assess the changes of tumor size conventional mp-MRI evaluation and baseline mp-MRI evaluation after the second course of modified GC neoadjuvant chemotherapy.
baseline, during the intervention(From the end date of the second course of NAC until one day before the third course of NAC, up to 7 weeks)
Changes from baseline tumor mp-MRI parameters after three course of modified GC neoadjuvant chemotherapy.
Time Frame: baseline, during the intervention(From the end date of the third course of NAC until one day before surgery, up to 10 weeks)
Using the built-in tools of the MRI imaging system to assess the changes of tumor size between conventional mp-MRI evaluation and baseline mp-MRI evaluation after the third course of modified GC neoadjuvant chemotherapy.
baseline, during the intervention(From the end date of the third course of NAC until one day before surgery, up to 10 weeks)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival.
Time Frame: through study completion，an average of 3 year
Evaluate the overall survival of patients accept the modified GC neoadjuvant chemotherapy followed by radical cystectomy and lymphadenectomy.
through study completion，an average of 3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Investigators

  • Principal Investigator: Lv Qiang, MD，PHD, The First Affiliated Hospital with Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Anticipated)

June 1, 2026

Study Completion (Anticipated)

June 1, 2026

Study Registration Dates

First Submitted

September 13, 2020

First Submitted That Met QC Criteria

October 8, 2020

First Posted (Actual)

October 19, 2020

Study Record Updates

Last Update Posted (Actual)

October 19, 2020

Last Update Submitted That Met QC Criteria

October 8, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-SR-252

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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