- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01016938
Dynamic Magnetic Resonance Imaging (MRI) for Lung Tumor Motion and Lung Function (GCC 0943)
Dynamic MRI for Lung Tumor Motion and Lung Function
Radiation treatment for each patient with cancer is designed based on CT scans. We know that tumors in the chest and abdomen move when you breathe. Because of this, there can be differences between planned treatment and the treatment actually delivered to the body. Usually with radiation a safety margin is added to ensure that radiation hits the entire tumor. This can damage healthy parts of the body because the exact location of the tumor is unknown.
Magnetic resonance imaging (MRI) is a painless and safe diagnostic procedure that uses a powerful magnet and radio waves to produce detailed images of the body's organs and structures, without the use of X-rays or other radiation.
The research doctors are studying to see if the position of a tumor can be tracked using MRI scans and tracking sensors placed on the skin. MRI scans and the tracking system used to calculate the location and position of the tumor are both FDA approved technologies.
The research doctors will also use the MRI scans to evaluate any changes in your lung function during and following your radiation treatments.
In this study the participant will undergo a series of MRI scans with and without contrast dye.
This study is being funded through grants from the National Institutes of Health (NIH).
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Maryland
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Baltimore, Maryland, Estados Unidos, 21201
- Ummc Msgcc
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Patients 18 years old or older
- Patients must be undergoing radiation therapy with or without chemotherapy for thoracic and/or abdominal cancers.
Exclusion Criteria:
- Pregnant or breast-feeding women are excluded. Negative serum or urine pregnancy test prior to study entry is required. Once on the protocol, the patient will be advised and expected to implement an accepted and effective method of contraception such as oral contraceptives (birthcontrol pill), intrauterine devices (IUDs), contraceptive implants under skin or contraceptive injections and condoms with foam.
- Patients with kidney disease of any severity or on hemodialysis.
- Patients who have metallic dental fillings or other metallic implants.
- Patients with known allergies to gadolinium-based contrast agents.
- Patients who have difficulty lying flat on their back for extended periods of time will be excluded
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
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Group I
This is a pilot study and there is only one group.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of Participants Whose Tumor Position is Visible Within ~2mm Using Cine-MRI Scans and External Sensors
Periodo de tiempo: 2 years
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Tumor tracking using cine-MRI and external surrogates with an accuracy of ~ 2mm. The participants' tumor size/margins were not specficially defined as long as it was visible/measurable on the MRI. |
2 years
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of Participants Whose Tumor Motion Could be Tracked Using Dynamic MRI w/ Contrast Post Radiation
Periodo de tiempo: 2 years
|
The internal margin (IM) is one half of the peak-to-peak displacement amplitude on 4D-CT images.
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2 years
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Warren D. D'Souza, PhD, UMMC MSGCC Department of Radiation Oncology
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HP-00043875
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