NCT00004936

MRI and CT Scans to Evaluate Invasive Cervical Cancer Before Treating Patients

Role of Radiology in the Pretreatment Evaluation of Invasive Cervical Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: —
• Sponsor: American College of Radiology Imaging Network · Network
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
DRUG	iodinated contrast dye
PROCEDURE	computed tomography
PROCEDURE	magnetic resonance imaging
RADIATION	gadopentetate dimeglumine

Timeline

• Start date: 2000-04-01
• Primary completion: 2001-05-01
• Completion: 2002-10-01
• First posted: 2003-01-27
• Last updated: 2013-01-28

Locations

2 sites across 1 country: United States