ACRIN 6651Role of Radiology in the Pretreatment Evaluation of Invasive Cervical Cancer
iodinated contrast dye
+ computed tomography
+ magnetic resonance imaging
Enfermedades Urogenitales+9
+ Enfermedades Genitales
+ Enfermedades del cuello uterino
Estudio Diagnóstico
Resumen
Fecha de inicio: 1 de abril de 2000
Fecha en la que se inscribió al primer participante.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.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Estudio Diagnóstico
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Mujer
Sexo biológico de los participantes elegibles para inscribirse.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
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
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene 2 ubicaciones
Morristown Memorial Hospital
Morristown, United StatesAbrir Morristown Memorial Hospital en Google MapsMemorial Sloan-Kettering Cancer Center
New York, United States