MRI and CT Scans to Evaluate Invasive Cervical Cancer Before Treating Patients
- Conditions
- Cervical Cancer
- Registration Number
- NCT00004936
- Lead Sponsor
- American College of Radiology Imaging Network
- Brief Summary
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.
- Detailed Description
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:
* Laparoscopic, transabdominal, or transvaginal hysterectomy
* Extrafascial total abdominal hysterectomy
* Trachelectomy Quality of life is assessed at 1 and 12 months.
Patients are followed every 3 months for 1 year and then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 465 patients will be accrued for this study within 18 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Morristown Memorial Hospital
🇺🇸Morristown, New Jersey, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States