ACRIN 6651Role of Radiology in the Pretreatment Evaluation of Invasive Cervical Cancer
iodinated contrast dye
+ computed tomography
+ magnetic resonance imaging
Urogenital Diseases+10
+ Genital Diseases
+ Uterine Cervical Diseases
Diagnostic Study
Summary
Study start date: April 1, 2000
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Diagnostic Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Morristown Memorial Hospital
Morristown, United StatesOpen Morristown Memorial Hospital in Google MapsMemorial Sloan-Kettering Cancer Center
New York, United States