Cervical Cancer Clinical Trial
Official title:
Role of Radiology in the Pretreatment Evaluation of Invasive Cervical Cancer
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.
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.
;
Primary Purpose: Diagnostic
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