Multi-parameter Magnetic Resonance Imaging Guides Precise Treatment of Urothelial Carcinoma
Multi-parameter Magnetic Resonance Imaging for Early Evaluation of the Efficacy of Neoadjuvant Chemotherapy With Modified GC Regimen for Urothelial Carcinoma
The First Affiliated Hospital with Nanjing Medical University
100 participants
Jan 1, 2018
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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.
- years old and older.
- Willing to give valid written informed consent.
- No contraindications to the MRI(magnetic resonance imaging) and MRI contrast agent.
Exclusion Criteria18
- 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.)
Interventions
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.
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.
The patient with muscle invasive bladder cancer will undergo radical cystectomy and pelvic lymph node dissection followed by a urinary tract reconstruction.
After two and three course of neoadjuvant chemotherapy, patient considered muscle invasive bladder cancer with baseline mpMRI will receive a conventional mpMRI scan.
Patient considered muscle invasive bladder cancer will receive a baseline mpMRI scan within one week before neoadjuvant chemotherapy.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04588168