Clinical trial · Interventional
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
NCT04588168CI-TRIAL-00047695unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Baseline Multiparametric MRI | Diagnostic Test | — | UNRESOLVED |
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| conventional Multiparametric MRI | Diagnostic Test | — | UNRESOLVED |
| Cystectomy and Lymphadenectomy | Procedure | — | UNRESOLVED |
| Immediate Multiparametric MRI | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental: Chemotherapy + mpMRI + surgery
- description
- Baseline mpMRI /Neoadjuvant chemotherapy /Immediate mpMRI /Cystectomy and Lymphadenectomy / Postoperative pathology Drug: Chemotherapy Procedure: Immediate Multiparametric MRI Procedure: Cystectomy and Lymphadenectomy
- interventionNames
- Drug: Chemotherapy
- Diagnostic Test: Immediate Multiparametric MRI
- Procedure: Cystectomy and Lymphadenectomy
- Diagnostic Test: conventional Multiparametric MRI
- Diagnostic Test: Baseline Multiparametric MRI
- type
- EXPERIMENTAL
- label
- Experimental: Chemotherapy + surgery
- description
- Baseline mpMRI /Neoadjuvant chemotherapy /Cystectomy and Lymphadenectomy / Postoperative pathology Drug: Chemotherapy Procedure: Cystectomy and Lymphadenectomy
- interventionNames
- Drug: Chemotherapy
- Procedure: Cystectomy and Lymphadenectomy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.)
References
Publications (14)
- BACKGROUNDRaghavan D. Chemotherapy and cystectomy for invasive transitional cell carcinoma of bladder. Urol Oncol. 2003 Nov-Dec;21(6):468-74. doi: 10.1016/s1078-1439(03)00145-5. PMID 14693275
- BACKGROUNDStein JP, Lieskovsky G, Cote R, Groshen S, Feng AC, Boyd S, Skinner E, Bochner B, Thangathurai D, Mikhail M, Raghavan D, Skinner DG. Radical cystectomy in the treatment of invasive bladder cancer: long-term results in 1,054 patients. J Clin Oncol. 2001 Feb 1;19(3):666-75. doi: 10.1200/JCO.2001.19.3.666. PMID 11157016
- BACKGROUNDGrossman HB, Natale RB, Tangen CM, Speights VO, Vogelzang NJ, Trump DL, deVere White RW, Sarosdy MF, Wood DP Jr, Raghavan D, Crawford ED. Neoadjuvant chemotherapy plus cystectomy compared with cystectomy alone for locally advanced bladder cancer. N Engl J Med. 2003 Aug 28;349(9):859-66. doi: 10.1056/NEJMoa022148. PMID 12944571
- BACKGROUNDGalsky MD, Pal SK, Chowdhury S, Harshman LC, Crabb SJ, Wong YN, Yu EY, Powles T, Moshier EL, Ladoire S, Hussain SA, Agarwal N, Vaishampayan UN, Recine F, Berthold D, Necchi A, Theodore C, Milowsky MI, Bellmunt J, Rosenberg JE; Retrospective International Study of Cancers of the Urothelial Tract (RISC) Investigators. Comparative effectiveness of gemcitabine plus cisplatin versus methotrexate, vinblastine, doxorubicin, plus cisplatin as neoadjuvant therapy for muscle-invasive bladder cancer. Cancer. 2015 Aug 1;121(15):2586-93. doi: 10.1002/cncr.29387. Epub 2015 Apr 14. PMID 25872978
- BACKGROUNDInternational Collaboration of Trialists; Medical Research Council Advanced Bladder Cancer Working Party (now the National Cancer Research Institute Bladder Cancer Clinical Studies Group); European Organisation for Research and Treatment of Cancer Genito-Urinary Tract Cancer Group; Australian Bladder Cancer Study Group; National Cancer Institute of Canada Clinical Trials Group; Finnbladder; Norwegian Bladder Cancer Study Group; Club Urologico Espanol de Tratamiento Oncologico Group; Griffiths G, Hall R, Sylvester R, Raghavan D, Parmar MK. International phase III trial assessing neoadjuvant cisplatin, methotrexate, and vinblastine chemotherapy for muscle-invasive bladder cancer: long-term results of the BA06 30894 trial. J Clin Oncol. 2011 Jun 1;29(16):2171-7. doi: 10.1200/JCO.2010.32.3139. Epub 2011 Apr 18.