Desarrollo de una técnica de imágenes por resonancia magnética (RM) de cuerpo entero libre de radiación para la estadificación de niños con cáncer
Desarrollo de una técnica de imagen por RM de cuerpo entero libre de radiación para la estadificación de niños con cáncer.
A research study on the diagnosis of spread of disease for children who have been diagnosed with solid tumors using a new whole body imaging technique and a new MR contrast agent (ferumoxytol). Standard tests that are used to determine the extent and possible spread of a child's disease include magnetic resonance (MR) imaging, computed tomography (CT), Positron Emission Tomography (PET) as well as bone scanning, and metaiodobenzylguanidine (MIBG) scanning. The purpose of this study is to determine if newer imaging tests referred to as whole body diffusion-weighted MR and whole body PET/MR can detect the extent and spread of the disease as accurately or even better as the standard tests (CT, MR and/or PET/CT). The advantage of the new imaging test is that it is associated with no or significantly reduced radiation exposure compared to standard CT and PET/CT imaging tests. The results of whole body MR and PET/MR will be compared with that of the conventional, standard imaging studies for tumor detecting.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Primary Objective: To compare the sensitivity, specificity and accuracy of WB-DW-MR scans (new technique) with 18F- FDG PET or 18F- FDG PET/CT or 18F- FDG PET/MR scans.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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Stanford, California, Estados Unidos, 94305
- Stanford University Cancer Institute
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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:
- Diagnosis of a solid extra-cranial tumor like malignant lymphoma or malignant sarcoma and
- Scheduled for or completed a 18F-FDG-PET or 18F-FDG-PET/CT tumor staging procedure.
- There will be no restrictions on prior treatment.
- Very young children who need sedation or anesthesia will be excluded from the study.
- In this pediatric & adult study, the participant or parent/guardian is consented, and the patient when a minor is given an assent form and involved in the discussion as appropriate.
Exclusion Criteria:
- MR-incompatible metal implants,
- need of sedation or claustrophobia.
- Hemosiderosis/hemochromatosis (patients can still be included in 2nd branch without ferumoxytol)
- There will be restrictions regarding use of other Investigational Agents: Pt with iron-overload will not receive Ferumoxytol
- History of allergic reactions to similar compounds will be obtained and patients with a positive history of allergic reaction to iron compounds or other severe allergic reactions.will be excluded from the study.
- Pregnant women and fetuses.
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 |
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Experimental: WB-DW-MR scan
simultaneous WB-DW-MR scan and 18-F FDG PET scan |
Otros nombres:
Otros nombres:
WB-DW-MR scans will be obtained on a 3T PET-MR system
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Area Under the Receiver Operating Characteristic Curve (ROC) of Maximum Standard Uptake Value (SUV)
Periodo de tiempo: Baseline (day of scan), and 3 to 14 weeks post treatment (interval determined by tumor type and treatment protocol)
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Clinical response prediction according to maximum Standard Uptake Value (SUV), assessed using receiver operating characteristic (ROC) curve analysis. Higher AUC values indicate better discrimination between responders and non-responders. |
Baseline (day of scan), and 3 to 14 weeks post treatment (interval determined by tumor type and treatment protocol)
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Area Under the Receiver Operating Characteristic Curve (ROC) of Minimum Apparent Diffusion Coefficient (ADC)
Periodo de tiempo: Baseline (day of scan), and 3 to 14 weeks post treatment (interval determined by tumor type and treatment protocol)
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Clinical response prediction according to minimum Apparent Diffusion Coefficient (ADC) values, assessed using receiver operating characteristic (ROC) curve analysis. The area under the ROC curve (AUC) measures the ability of minimum ADC values to distinguish responders from non-responders, with higher AUC values indicating better predictive performance. |
Baseline (day of scan), and 3 to 14 weeks post treatment (interval determined by tumor type and treatment protocol)
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Sensitivity and Specificity of WB-DW-MR Compared to 18F-FDG PET/CT
Periodo de tiempo: 3 to 14 weeks post-treatment (interval determined by tumor type and treatment protocol)
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Comparison of the sensitivity (true positive rate) and specificity (true negative rate) of WB-DW-MR scans versus standard 18F-FDG PET/CT scans for tumor detection and clinical response assessment, using imaging findings compared with the clinical reference standard (biopsy and/or follow-up imaging). |
3 to 14 weeks post-treatment (interval determined by tumor type and treatment protocol)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Signal-to-Noise Ratio as a Measure of Technical Optimization of Whole-Body Diffusion-Weighted MRI (WB-DW-MRI)
Periodo de tiempo: Baseline (day of scan)
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Signal-to-noise ratio (SNR) was assessed to evaluate and optimize pulse sequence parameters and b-values for whole-body diffusion-weighted MRI. SNR was calculated from signal intensity measurements obtained from bone marrow metastases and normal bone marrow regions on diffusion-weighted MRI images. b50 images provide higher signal-to-noise ratio and visualization of tissue perfusion/anatomy, while b800 images emphasize restricted diffusion associated with malignancy and suppress background tissue signal. |
Baseline (day of scan)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Heike Daldrup-Link, Stanford University
Publicaciones y enlaces útiles
Publicaciones Generales
- Theruvath AJ, Siedek F, Yerneni K, Muehe AM, Spunt SL, Pribnow A, Moseley M, Lu Y, Zhao Q, Gulaka P, Chaudhari A, Daldrup-Link HE. Validation of Deep Learning-based Augmentation for Reduced 18F-FDG Dose for PET/MRI in Children and Young Adults with Lymphoma. Radiol Artif Intell. 2021 Oct 6;3(6):e200232. doi: 10.1148/ryai.2021200232. eCollection 2021 Nov.
- Theruvath AJ, Siedek F, Muehe AM, Garcia-Diaz J, Kirchner J, Martin O, Link MP, Spunt S, Pribnow A, Rosenberg J, Herrmann K, Gatidis S, Schafer JF, Moseley M, Umutlu L, Daldrup-Link HE. Therapy Response Assessment of Pediatric Tumors with Whole-Body Diffusion-weighted MRI and FDG PET/MRI. Radiology. 2020 Jul;296(1):143-151. doi: 10.1148/radiol.2020192508. Epub 2020 May 5.
- Klenk C, Gawande R, Uslu L, Khurana A, Qiu D, Quon A, Donig J, Rosenberg J, Luna-Fineman S, Moseley M, Daldrup-Link HE. Ionising radiation-free whole-body MRI versus (18)F-fluorodeoxyglucose PET/CT scans for children and young adults with cancer: a prospective, non-randomised, single-centre study. Lancet Oncol. 2014 Mar;15(3):275-85. doi: 10.1016/S1470-2045(14)70021-X. Epub 2014 Feb 19.
- Rashidi A, Baratto L, Theruvath AJ, Greene EB, Jayapal P, Hawk KE, Lu R, Seekins J, Spunt SL, Pribnow A, Daldrup-Link HE. Improved Detection of Bone Metastases in Children and Young Adults with Ferumoxytol-enhanced MRI. Radiol Imaging Cancer. 2023 Mar;5(2):e220080. doi: 10.1148/rycan.220080.
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 (Estimado)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRB-20221
- NCI-2012-015321 (Otro identificador: National Cancer Institute: Clinical Trials Reporting Program)
- 1R01CA269231-01A1 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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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