MRI- and PET-Predictive-Assay of Treatment Outcome in Cancer of the Cervix
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 51
- 试验地点
- 6
- 主要终点
- Predictive power of the MRI and PET/CT parameters
研究概览
简要总结
This trial studies magnetic resonance imaging (MRI) and positron emission tomography (PET) imaging in predictive treatment response in patients with stage IB-IVA cervical cancer. MRI is a procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. PET is a procedure in which a small amount of radioactive glucose (sugar) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the glucose is taken up. Comparing results of diagnostic procedures, such as MRI and PET, done before, during and after radiation and chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment.
详细描述
OUTLINE:
Patients undergo radiation therapy and receive chemotherapy per standard of care. Patients undergo dynamic contrast-enhanced (DCE) MRI, diffusion-weighted (DW) MRI, and magnetic resonance (MR) spectroscopy at baseline, 2-2.5 weeks, 4-5 weeks, and 1 month following radiation therapy completion, and fludeoxyglucose F 18 (FDG) PET/computed tomography (CT) at baseline, 2-2.5 weeks, and 4-5 weeks.
After completion of study, patients are followed up at least every 3-6 months for 5 years.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients must have histologically confirmed stage IB2-IVA epithelial carcinoma of the cervix, including squamous cell, adeno-, and undifferentiated carcinoma, and excluding small cell/neuroendocrine carcinoma, who will undergo radiation therapy for cervical cancer with curative intent
- •Surgical staging with retroperitoneal staging and lymphadenectomy is permitted
- •Patients who will undergo standard radiation therapy with concurrent cisplatin-based chemotherapy for cervical cancer
- •Patients with no prior radiation therapy to the pelvis
- •Patients with no contra-indications to magnetic resonance (MR) imaging
- •Patients must have adequate renal function: glomerular filtration rate (GFR) > 30 mL/min/1.73 m^2; for the test-retest sub-study MRI, patients must have a GFR of > 60 mL/min/1.73m^2
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •Patients with small cell/neuroendocrine cervical carcinoma
- •Patients who have received any prior pelvic radiation therapy in the area of the tumor that precludes the delivery of a curative dose of pelvic radiation
- •Medical contraindication to MR imaging (e.g. pacemakers, metallic implants, aneurysm clips, known contrast allergy to gadolinium contrast, pregnancy, nursing mothers, weight greater than 350 pounds, GFR < 30)
- •Major medical or psychiatric illness that, in the investigator's opinion, would prevent completion of treatment, completion of the study protocol, or interfere with follow-up
- •Life expectancy of less than 6 months
结局指标
主要结局
Predictive power of the MRI and PET/CT parameters
时间窗: Up to 5 years
Hazard ratios will be calculated. Predictive power of the heterogeneity metrics will be compared and ranked with Federation of Gynecology and Obstetrics stage, lymph node status, histology, hemoglobin level, and tumor anatomic volumes. Multivariate predictive algorithms will be derived by synergizing the predictive power of imaging metrics and clinical prognosticators for clinical translation.
Disease-free survival
时间窗: Up to 5 years
Distant metastatic rate
时间窗: Up to 5 years
Local control
时间窗: Up to 5 years
Clinical/pelvic examination, pap smear, other standard of care investigations as indicated by clinical findings.
次要结局
未报告次要终点