MRI and CT Scans to Evaluate Invasive Cervical Cancer Before Treating Patients (ACRIN 6651)
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.
Drug: iodinated contrast dye
Procedure: computed tomography
Procedure: magnetic resonance imaging
Radiation: gadopentetate dimeglumine
|Study Design:||Primary Purpose: Diagnostic|
|Official Title:||Role of Radiology in the Pretreatment Evaluation of Invasive Cervical Cancer|
|Study Start Date:||April 2000|
|Study Completion Date:||October 2002|
|Primary Completion Date:||May 2001 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004936
|United States, New Jersey|
|Morristown Memorial Hospital|
|Morristown, New Jersey, United States, 07962-1956|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Hedvig Hricak, MD, PhD||Memorial Sloan-Kettering Cancer Center|