* Known bladder cancer
* Scheduled for radical cystectomy and lymph node dissection.
* Able and willing to give valid written informed consent.
* No contraindications to the MRI(magnetic resonance imaging).
Exclusion Criteria:
* Not pregnant, planning to become pregnant during the study, or nursing.
* No allergy to contrast agents.
* Patient with significant renal insufficiency, i.e. an estimated glomerular filtration rate(eGRF) less than 30 mL/min/1.73m2.
* Any condition conflict based on the investigation's clinical judgment that would prevent the patient from completion all trial assessments and visits.
* Inability or unwillingness to cooperate with requirements of this trial.
* Patients who exhibit noticeable anxiety and/or claustrophobia or who exhibit severe vertigo when they are moved into the MR.
* Patients with sickle cell anemia and other hemolytic anemia.
Source : Importé depuis le centre
Cohortes
Thérapie ou Intervention proposée
Cohortes
Nom
Condition médicale
Traitement
État du recrutement
MRI+surgery
3 Tesla MRI/Cystectomy and Lymphadenectomy/Urinary Diversion/Specimen Ultra-High field MRI
Donnée non disponible
Inconnu
MRI+surgery+chemotherapy
3 Tesla MRI/Cystectomy and Lymphadenectomy/Urinary Diversion/Specimen Ultra-High field MRI/chemotherapy
Donnée non disponible
Inconnu
MRI+surgery
État du recrutement
unknown
3 Tesla MRI/Cystectomy and Lymphadenectomy/Urinary Diversion/Specimen Ultra-High field MRI
MRI+surgery+chemotherapy
État du recrutement
unknown
3 Tesla MRI/Cystectomy and Lymphadenectomy/Urinary Diversion/Specimen Ultra-High field MRI/chemotherapy
Données à jour depuis :
10 avril 2025
Description de l'étude
Description de l'étude
Résumé de l'étude
RATIONALE: New diagnostic procedures, such as 3 Tesla magnetic resonance imaging (MRI), may help find bladder cancer and learn the extent of disease.
PURPOSE: This clinical trial is studying how well 3 Tesla MRI works in finding cancer in patients with bladder cancer.
Source : Importé depuis le centre
OBJECTIVES:
Primary
* To evaluate whether 3 Tesla MRI can accurately determine the primary tumor (T) stage and pelvic lymph nodes (N) stage in patients with localized bladder cancer as compared to histopathology staging.
Secondary
* To determine whether 3 Tesla MRI can determine if the primary bladder tumor is responding to neoadjuvant chemotherapy at the mid-point of the planned treatment (after 2 courses).
* To assess whether an ex-vivo ultra-high-field MRI (4.7-11.7 Tesla) tissue scan can more accurately determine clinical stage of a primary bladder tumor and local extent of the disease (i.e., involvement of contiguous organs and regional lymph nodes) as compared to histopathology staging.
OUTLINE: Patients may receive neoadjuvant chemotherapy (typically four 21-day courses of cisplatin-based therapy) followed by standard radical cystectomy and lymph node dissection.
Patients undergo a 3 Tesla MRI scan at baseline to stage the primary tumor, regional lymph nodes, and to rule out distant sites of disease. The MRI includes diagnostic high-resolution anatomical images (e.g., T1-weighted and T2-weighted images along axial or optimal directions) and experimental images including functional MRI (e.g., dynamic contrast-enhanced MRI, diffusion-weighted MRI, MR spectroscopy, and chemical exchange-dependent saturation-transfer imaging). Patients also undergo a 3 Tesla MRI scan after 2 courses of neoadjuvant chemotherapy and after completion of neoadjuvant chemotherapy. Patients not receiving neoadjuvant chemotherapy undergo a 3 Tesla MRI scan 2-4 weeks before radical cystectomy and lymph node dissection.
Specimens from the radical cystectomy and pelvic lymph node dissection are examined ex-vivo by ultra-high-field MRI and the Micro-Imaging Specimen Study Form is completed. The specimens are then examined by the pathology department as per standard routine.
Source : Importé depuis le centre
Centres participants
Sites
Centres participants
1
centres
OHIO STATE UNIVERSITY MEDICAL CENTER
Columbus
OHIO, UNITED STATES
Recrutement local
État du recrutement:
FERMÉ
Source d'information
Dernière modification :
10 avril 2025
Données à jour depuis :
12 avr.
Origine des données :
clinicaltrials.gov