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OSU-08063

3 tesla mri in patients with bladder cancer
Source : Importé depuis le centre

Référence clinicaltrials.gov: NCT00938145
recurrent bladder cancer
stage II bladder cancer
stage III bladder cancer
stage IV bladder cancer
Source : Importé depuis le centre
Recrutement fermé
Dernière modification : 2025/04/10
Type de recherche

Interventionnel


Population cible

Condition médicale (spécialité visée)

Donnée non disponible

Profil des participants

Sexe(s) des participants

ALL

Source : Importé depuis le centre

Critères de sélection

Critères d'inclusion

Inclusion Criteria:

* 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

Thérapie ou Intervention proposée

Cohortes
MRI+surgery
État du recrutement
unknown
MRI+surgery+chemotherapy
État du recrutement
unknown
Données à jour depuis : 10 avril 2025

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

Sites

Centres participants

    1 centres
  • OHIO STATE UNIVERSITY MEDICAL CENTER

    Columbus

    OHIO, UNITED STATES

    Recrutement local
    État du recrutement: FERMÉ

Dernière modification : 10 avril 2025
Données à jour depuis : 12 avr.
Origine des données : clinicaltrials.gov
Référence clinicaltrials.gov: NCT00938145