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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Role of Radiology in the Pretreatment Evaluation of Invasive Cervical Cancer

Conditions
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Cervical Cancer

Intervention / Treatment
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* Drug: iodinated contrast dye
* Procedure: computed tomography
* Procedure: magnetic resonance imaging
* Radiation: gadopentetate dimeglumine


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed invasive cervical cancer, including invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma FIGO stage IB1 with clinically visible gross lesion OR FIGO stage IB2 or greater Scheduled for one of the following surgeries at a participating Gynecological Oncology Group center: Laparoscopic, transabdominal, or transvaginal hysterectomy Extrafascial total abdominal hysterectomy Trachelectomy Not scheduled for a loop electrosurgical excision procedure or a cone biopsy only PATIENT CHARACTERISTICS: Age: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: No cardiac pacemakers Pulmonary: No asthma Other: Not pregnant No contraindication to computed tomography (CT) (e.g., history of allergy to CT contrast medium) No contraindication to magnetic resonance imaging (e.g., intracranial vascular clip) No nonmalignant general medical or psychiatric condition that would preclude consent or surgery PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy for invasive cervical cancer Surgery: See Disease Characteristics No prior surgery for invasive cervical cancer Other: No prior medical treatment for invasive cervical cancer
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: iodinated contrast dye|nan|
|Procedure: computed tomography|nan|
|Procedure: magnetic resonance imaging|nan|
|Radiation: gadopentetate dimeglumine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage III cervical cancer, stage IB cervical cancer, stage IIB cervical cancer, stage IVB cervical cancer, stage IIA cervical cancer, stage IVA cervical cancer, cervical squamous cell carcinoma, cervical adenocarcinoma, cervical adenosquamous cell carcinoma