MRI and CT Scans to Evaluate Invasive Cervical Cancer Before Treating Patients (ACRIN 6651)
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|ClinicalTrials.gov Identifier: NCT00004936|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : January 28, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer||Drug: iodinated contrast dye Procedure: computed tomography Procedure: magnetic resonance imaging Radiation: gadopentetate dimeglumine||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Role of Radiology in the Pretreatment Evaluation of Invasive Cervical Cancer|
|Study Start Date :||April 2000|
|Actual Primary Completion Date :||May 2001|
|Actual Study Completion Date :||October 2002|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|