Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04588168

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

Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2020-10-19

100

Participants Needed

1

Research Sites

439 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Pathologically confirmed primary or recurrent bladder cancer.
  • Planned to undergo transurethral resection of bladder tumor (TURBT) or modified gemcitabine-cisplatin (GC) neoadjuvant chemotherapy plus radical total cystectomy.
  • 18 years old and older.
  • Willing to give valid written informed consent.
  • No contraindications to the MRI and MRI contrast agent.
Not Eligible

You will not qualify if you...

  • Abnormal liver function (1.5 times higher than normal).
  • Glomerular filtration rate less than 60 ml/min·kg.
  • Heart failure.
  • Acute myocardial infarction.
  • Severe heart and lung disease.
  • Hypotension and hypoxia.
  • Brain metastases or other known central nervous system metastases.
  • 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, or other active infections.
  • Pregnant or lactating women.
  • Participation in other drug trials.
  • Poor general condition (e.g., malnutrition, dehydration) with Behavioral status score (ZPS quintile) ≥ 2.
  • Previous or existing autoimmune diseases (including treated or untreated).
  • Organ transplantation or requiring long-term immunosuppressive agents.
  • Intolerance or allergy to cytotoxic chemotherapeutic drugs.
  • Bone marrow transplantation or severe leukopenia.
  • Severe infection or trauma.
  • Any condition judged clinically unsuitable to complete the study, such as poor compliance or treatment incompatibility.

AI-Screening

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Trial Site Locations

Total: 1 location

1

The first affiliated hospital of Nanjing Medical University

Nanjing, Jiangsu, China, 210000

Actively Recruiting

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Research Team

Y

Yuan Baorui

CONTACT

L

Lv Qiang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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