Using MRI to Improve Treatment for Bladder Cancer

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

This study is testing if special MRI scans can help doctors see how well a new chemotherapy treatment works for people with muscle invasive bladder cancer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The First Affiliated Hospital with Nanjing Medical University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT04588168 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of multiparametric MRI in assessing the sensitivity of modified neoadjuvant chemotherapy in patients with muscle invasive bladder cancer (MIBC). Patients will undergo baseline MRI scans to stage their tumors and will receive chemotherapy followed by radical cystectomy. The study aims to determine if MRI can predict treatment outcomes and monitor early changes in tumor response during chemotherapy. The approach includes multiple MRI assessments throughout the treatment process to gather comprehensive data on tumor behavior.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with pathologically confirmed muscle invasive or recurrent bladder cancer who are scheduled for neoadjuvant chemotherapy.

Not a fit: Patients with severe comorbidities, contraindications to MRI, or those with non-muscle invasive bladder cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more personalized and effective treatment strategies for patients with bladder cancer.

How similar studies have performed: While the use of MRI in cancer treatment monitoring is established, this specific application in bladder cancer treatment is relatively novel and has not been extensively tested.

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.)

Where this trial is running

Nanjing, Jiangsu

• The first affiliated hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Principal investigator: Lv Qiang, MD，PHD — The First Affiliated Hospital with Nanjing Medical University
• Study coordinator: Yuan Baorui

Conditions Bladder Cancer; Multiparametric Magnetic Resonance Imaging; Chemotherapy