NCT00004936已完成不适用
Role of Radiology in the Pretreatment Evaluation of Invasive Cervical Cancer
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Imaging procedures such as MRI or CT scans may improve the ability to detect cervical cancer and determine the extent of disease.
PURPOSE: Diagnostic trial to determine the effectiveness of MRI and CT scans in evaluating invasive cervical cancer before treatment of patients.
详细描述
OBJECTIVES:
- Compare the diagnostic performance of magnetic resonance imaging (MRI), computed tomography (CT), and clinical FIGO staging in patients with invasive cervical cancer.
- Compare the accuracy of MRI, CT, and clinical FIGO staging in the evaluation of morphologic tumor prognostic factors in FIGO stage IB1 and stage IB2 and greater in these patients.
- Examine the value of imaging assessment of tumor prognostic factors (alone or in combination) as predictors of recurrence within 2 years of surgery in these patients.
- Evaluate the quality of life in the 12-month period after staging and treatment to potentially change staging accuracy.
OUTLINE: This is a multicenter study.
Patients undergo a computed tomography scan with iodinated contrast dye followed by a magnetic resonance imaging scan with or without contrast comprising gadopentetate dimeglumine or vice versa.
Within 6 weeks of first protocol imaging study, patients undergo one of the following surgeries:
研究设计
- 研究类型
- Interventional
- 主要目的
- Diagnostic
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed invasive cervical cancer, including invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma
- •FIGO stage IB1 with clinically visible gross lesion OR
- •FIGO stage IB2 or greater
- •Scheduled for one of the following surgeries at a participating Gynecological Oncology Group center:
- •Laparoscopic, transabdominal, or transvaginal hysterectomy
- •Extrafascial total abdominal hysterectomy
- •Trachelectomy
- •Not scheduled for a loop electrosurgical excision procedure or a cone biopsy only
- •PATIENT CHARACTERISTICS:
- •Not specified
- •Performance status:
- •Not specified
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •Not specified
- •Not specified
- •Cardiovascular:
- •No cardiac pacemakers
- •No asthma
- •Not pregnant
- •No contraindication to computed tomography (CT) (e.g., history of allergy to CT contrast medium)
- •No contraindication to magnetic resonance imaging (e.g., intracranial vascular clip)
- •No nonmalignant general medical or psychiatric condition that would preclude consent or surgery
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •No prior chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •No prior radiotherapy for invasive cervical cancer
- •See Disease Characteristics
- •No prior surgery for invasive cervical cancer
- •No prior medical treatment for invasive cervical cancer
排除标准
- 未提供
研究者
研究点 (2)
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