Pilot Study of Role of MRI in Neoadjuvant Chemotherapy for Bladder Cancer
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Complete pathologic response
研究概览
简要总结
This is a prospective study of pretreatment DW-MRI to identify potential imaging biomarkers predictive of response to neoadjuvant chemotherapy in patients with muscle-invasive bladder cancer. Target enrollment of this study is 40 patients. Patients will first undergo baseline DW-MRI of the Abdomen and Pelvis prior to beginning standard treatment with neoadjuvant cisplatin-based chemotherapy after which DW-MRI will be repeated to assess for response or progression. Patients who remain eligible for surgery will proceed to standard radical cystectomy with pelvic lymph node dissection. DW-MRI metrics including apparent diffusion coefficient (ADC) values will be correlated to pathologic response rate in the radical cystectomy specimen to identify imaging markers predictive of response.
详细描述
Purpose:
Primary Endpoint:
- To assess the feasibility of using pre-treatment ADC as a predictor of complete pathologic response to neo-adjuvant chemotherapy at radical cystectomy
Secondary Endpoint:
- To explore the association between pre-treatment ADC values and complete pathologic response to neoadjuvant chemotherapy at radical cystectomy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed muscle invasive urothelial carcinoma of the bladder
- •Clinical stage T2-T4a N0/X M0 disease
- •Age ≥ 18 years of age
- •Medically appropriate candidate for radical cystectomy, as per NYU Attending Urologic Oncologist
- •Medically appropriate candidate for cisplatin-based neoadjuvant chemotherapy as per NYU Attending Medical Oncologist
- •If female of childbearing potential, pregnancy test is negative
排除标准
- •Prior systemic chemotherapy (prior intravesical therapy is allowed)
- •Prior radiation therapy to the bladder
- •Medical contraindication to cisplatin-based neoadjuvant chemotherapy as determined by NYU Attending Medical Oncologist
- •Concomitant use of any other investigational drugs
- •Inability to tolerate MRI including conditions such as claustrophobia or inability to lay flat for > 45 minutes.
- •Presence of pacemaker/ICD or perfusion pumps
- •Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial heart, valves with steel parts, metal fragments, shrapnel, bullets, tattoos near the eye, or steel implants.
- •Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study
结局指标
主要结局
Complete pathologic response
时间窗: Under one year
次要结局
未报告次要终点