- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01672021
Initial Assessment of 18FDG-PET/MRIin Determining the Extent of Systemic Disease in Breast Cancer Patients
Initial Assessment of 18FDG-PET/MRI in Determining the Extent of Systemic Disease in Breast Cancer Patients.
Descripción general del estudio
Descripción detallada
This study is an initial assessment of the ability of 18FDG-PET/MR imaging to detect systemic disease in breast cancer patients as compared with conventional 18FDG-PET/CT.
Rationale: Accurate assessment of the extent systemic disease in breast cancer patients both initially and throughout treatment and surveillance comprises the basis for clinical care including surgical planning, radiation and drug selection. Shortcomings in FDG-PET/CT, a common current method of disease detection and surveillance, include decreased sensitivity in brain, liver and bone and a relatively high radiation dose, which could cause up to 5 new cancers per 1,000 patients (young American women) per scan. Initial studies assessing whole body MRI, a technique which involves no radiation, in the staging of breast cancer patients show promise, but can suffer from decreased ability to detect nodal disease and from detection of false positive lesions. Manual fusion of PET and MRI data in bowel and breast organ systems has been shown to decrease false positive lesions as compared with MRI alone. In the past year, molecular MRI imaging machines which combine PET and MRI imaging have become available for research purposes.
Hypothesis 1: We therefore hypothesize that FDG-PET/MRI will provide concordant or improved lesion detection as compared with FDG-PET/CT in breast cancer patients at a decreased radiation dose.
Hypothesis 2: In addition, the simultaneously acquired PET and MRI data allows for analysis of local tumor characteristics including perfusion, cellularity and glucose metabolism. In the subgroup of patients with an index breast cancer, we hypothesize that these local tumor metrics correlate with number and sites of systemic lesions.
Methods: All newly diagnosed breast cancer patients who are undergoing imaging evaluation for initial extent of disease or disease surveillance at NYU Cancer Center and Bellevue hospital are candidates for study in this protocol. Patients will be invited for follow-up FDG-PET/MRI imaging at any time they are undergoing FDG-PET/CT as part of their clinical care.
Subjects are undergoing FDG-PET/CT at the Cancer Center on 34th St and Lexington Avenue as part of routine care and will be transferred directly to the 38th St. facility by car in a timely manner so that an additional dose of 18-FDG labeled glucose will be unnecessary for the experimental FDG-PET/MRI.
FDG-PET/MRI will be performed and is estimated to 45-60 minutes of scanning time. The patient will then be free to leave the department. Data will be transferred to a workstation and interpreted by two independent radiologists. Size and location of each lesion will be recorded in a confidentiality protected spreadsheet for each component of the scan and the lesion load will be defined by the union of all detected lesions from all three components (DCE-MRI, diffusion-weighted imaging (DWI), FDG-PET). Data will be compared on a per lesion, per organ system and per patient basis with the patient's routine FDG-PET/CT for presence of metastatic disease and size and number of metastatic lesions.
In the case where PET/MRI demonstrates metastatic disease not seen on routine modalities, the referring physician will be alerted. Additional dedicated radiologic studies and biopsy may be recommended and performed at the discretion of the referring physician.
Results: Results of FDG-PET/MRI and FDG-PET/CT findings will be reported in a descriptive format together with related biopsy results and histopathologic correlation. An exact 95% confidence interval will be derived for the true percentage of times the assessment of disease state lesion, per organ system and per patient from FDG-PET/MRI will be concordant with the assessments derived for the same patient using the FDG-PET/CT. In patients with an index breast cancer, Pearson and Spearman rank correlations will be used to characterize the association between local tumor metrics and metastatic burden and location.
Potential benefits: 1. Equal or improved ability to detect metastatic disease in breast cancer patients at a decreased radiation dose. 2. An improved understanding of index tumor metrics help stratify risk for metastatic disease based on the index tumor and enable individually tailored surveillance.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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New York
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New York, New York, Estados Unidos, 10016
- NYU School of Medicine
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
Any patient with a history or breast cancer undergoing PET/CT either for initial staging or for disease surveillance
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Exclusion Criteria:
- Pregnant patients and patients with known contraindications for whole body MR imaging (e.g., pacemakers, recent surgery, brain vascular clips, etc.) will be excluded from the study. Patients will be screened with a questionnaire to be sure they have no medical devices that could make the procedure unsafe. Patients with glomerular filtration rate (GFR) < 15 ml/min/1.73m2 or who are on dialysis will be excluded from the study.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Otro: PET/MRI
|
TEP/RM
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Number of metastatic lesions seen on PET/MRI as compared with PET/CT
Periodo de tiempo: 1 year
|
1 year
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Patient stage as imaged by PET/MRI as compared with PET/CT
Periodo de tiempo: 1 year
|
1 year
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Laura Heacock, MD, NYU School of Medicine
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 12-02243
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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