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

Primary Purpose

Bladder Cancer

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Chemotherapy

Immediate Multiparametric MRI

Cystectomy and Lymphadenectomy

conventional Multiparametric MRI

Baseline Multiparametric MRI

About this trial

This is an interventional diagnostic trial for Bladder Cancer focused on measuring Multiparametric Magnetic Resonance Imaging, Bladder Cancer, Chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

The first affiliated hospital of Nanjing Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Experimental: Chemotherapy + mpMRI + surgery

Experimental: Chemotherapy + surgery

Arm Description

Baseline mpMRI /Neoadjuvant chemotherapy /Immediate mpMRI /Cystectomy and Lymphadenectomy / Postoperative pathology Drug: Chemotherapy Procedure: Immediate Multiparametric MRI Procedure: Cystectomy and Lymphadenectomy

Baseline mpMRI /Neoadjuvant chemotherapy /Cystectomy and Lymphadenectomy / Postoperative pathology Drug: Chemotherapy Procedure: Cystectomy and Lymphadenectomy

Outcomes

Primary Outcome Measures

Changes from baseline tumor mp-MRI parameters at immediate mp-MRI evaluation.

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.

Secondary Outcome Measures

Changes from baseline tumor mp-MRI parameters after two course of modified GC neoadjuvant chemotherapy.

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.

Changes from baseline tumor mp-MRI parameters after three course of modified GC neoadjuvant chemotherapy.

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.

Full Information

NCT ID

NCT04588168

First Posted

September 13, 2020

Last Updated

October 8, 2020

Sponsor

The First Affiliated Hospital with Nanjing Medical University

1. Study Identification

Unique Protocol Identification Number

NCT04588168

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Recruiting

Study Start Date

January 1, 2018 (Actual)

Primary Completion Date

June 2026 (Anticipated)

Study Completion Date

June 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The First Affiliated Hospital with Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bladder Cancer

Keywords

Multiparametric Magnetic Resonance Imaging, Bladder Cancer, Chemotherapy

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental: Chemotherapy + mpMRI + surgery

Arm Type

Experimental

Arm Description

Arm Title

Experimental: Chemotherapy + surgery

Arm Type

Experimental

Arm Description

Baseline mpMRI /Neoadjuvant chemotherapy /Cystectomy and Lymphadenectomy / Postoperative pathology Drug: Chemotherapy Procedure: Cystectomy and Lymphadenectomy

Intervention Type

Drug

Intervention Name(s)

Chemotherapy

Other Intervention Name(s)

Neoadjuvant chemotherapy

Intervention Description

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.

Intervention Type

Diagnostic Test

Intervention Name(s)

Immediate Multiparametric MRI

Other Intervention Name(s)

Multiparameter magnetic resonance imaging

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Cystectomy and Lymphadenectomy

Other Intervention Name(s)

surgery

Intervention Description

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

Intervention Type

Diagnostic Test

Intervention Name(s)

conventional Multiparametric MRI

Other Intervention Name(s)

Multiparameter magnetic resonance imaging

Intervention Description

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

Intervention Type

Diagnostic Test

Intervention Name(s)

Baseline Multiparametric MRI

Other Intervention Name(s)

Multiparameter magnetic resonance imaging

Intervention Description

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

Primary Outcome Measure Information:

Title

Changes from baseline tumor mp-MRI parameters at immediate mp-MRI evaluation.

Description

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)

Secondary Outcome Measure Information:

Title

Changes from baseline tumor mp-MRI parameters after two course of modified GC neoadjuvant chemotherapy.

Description

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)

Title

Changes from baseline tumor mp-MRI parameters after three course of modified GC neoadjuvant chemotherapy.

Description

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)

Other Pre-specified Outcome Measures:

Title

Overall survival.

Description

Evaluate the overall survival of patients accept the modified GC neoadjuvant chemotherapy followed by radical cystectomy and lymphadenectomy.

Time Frame

through study completion，an average of 3 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yuan Baorui

Phone

+86 18351998926

yuanbr960720@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Lv Qiang

Phone

+86 13505196501

doctorlvqiang@sina.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lv Qiang, MD，PHD

Organizational Affiliation

The First Affiliated Hospital with Nanjing Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The first affiliated hospital of Nanjing Medical University

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Qiang Lu, PhD

Phone

13505196501

dxhlvqiang@163.com

First Name & Middle Initial & Last Name & Degree

Pengchao Li, PhD

Phone

13584025756

superkulian@aliyun.com

12. IPD Sharing Statement

Plan to Share IPD

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

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