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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05396183
Accuracy and Safety of Coplanar Template Assistance for Head and Neck Biopsies.
A Prospective Single-arm Cohort Study on Accuracy and Safety of Coplanar Template Assisted CT-guided Neck and Head Biopsies.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Tumors in head and neck region refer to those located above the clavicle, the upper boundary is the skull base, the posterior boundary is cervical vertebra, excluding brain spinal cord and other central nervous system and Intraocular tumor. Include oral cavity (lips, tongue, hard palate, floor of mouth, gums), oropharynx (middle of throat behind mouth, including tongue base, tonsils, and soft palate), larynx, hypopharynx (lower throat), paranasal sinuses, nasopharynx, salivary glands (Parotid, submandibular and minor salivary glands), thyroid, skin cancers and metastatic cancers of the head and neck. Tissue sampling of lesions in the head and neck is limited due to the complex regional anatomy, including nerves, vessels, and salivary glands. Computed tomography (CT)-guided percutaneous puncture biopsy is a well-recognized technique that can facilitate histopathological diagnosis and therapeutic planning of head and neck masses, and may be particularly useful when lesions are not accessible via an endoscope or by palpation-guided sampling. CT image-guided free-hand puncture biopsy is widely used in clinical practice. However, multiple CT scan and adjustment of position of the biopsy needle increased radiation exposure and the probability of other adverse events, such as bleeding and nerve injury. Therefore, we need a more efficient approach to guidance which is precisely positioned and safe to operate.
In recent years, we have taken advantage of three-dimensional(3D) printing template to improve the accuracy and safety of puncture related operations, which simplifies the procedure and shortens the procedure duration[3-4]. 3D printing template include co-planar and non co-planar[5]. However, few prospective studies have focused on three-dimensional printing co-planer template(3D-PCT) for CT-guided neck and head biopsy. The purposes of this prospective, single-arm study are to determine the accuracy and safety of CT guided percutaneous head and neck biopsy assisted by 3D-PCT.
- Tu A S, Geyer C A, Mancall A C, et al. The buccal space: A doorway for percutaneous CT-guided biopsy of the parapharyngeal region. Am J Neuroradiol, 1998.19(4):728- 731.
- Esposito M B, Arrington J A, Murtagh F R, et al. Anterior approach for CT-guided biopsy of skull base and parapharyngeal space lesions. J Comput Assist Tomogr, 1996. 20 (5):739-741.
- Ji Z, Jiang Y ,Guo F, et al. Dosimetry verification of radioactive seed implantation for malignant tumor assisted by 3D printing individual templates and CT guidance. Applied Radiation and lsotopes 2017; 124: 68-74.
- Jiang Y, Ji Z , Guo F, et al. Side effects of CT-guided implantation of 125I seeds for recurrent malignant tumors of the head and neck assisted by 3D printing non co-planar template[J]. Radiation Oncology, 2018, 13(1):18.
- W J, Chai S, Wang R, et al. Expert consensus on computed tomography-assisted three-dimensional-printed coplanar template guidance for interstitial permanent radioactive (125) I seed implantation therapy. J Cancer Res Ther 2019; 15: 1430-1434.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Bin Qiu, MD
- Número de teléfono: 010-82265968
- Correo electrónico: 15269757106@163.com
Ubicaciones de estudio
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Beijing
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Beijing, Beijing, Porcelana, 10010
- Reclutamiento
- Department of Radiation Oncology of Peking university third hospital
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Contacto:
- Bin Qiu, MD
- Número de teléfono: 01082265968
- Correo electrónico: 542122203@qq.com
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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:
(1) Ages 18 to 80; (2) KPS>70 points, an estimated life expectancy of greater than 3 months; (3)Head and neck masses or nodules can be revealed by CT scan, MRI or ultrasonic examination; (4) Without taking drugs affecting coagulation and/or platelet aggregation are used; If used, the drug has been discontinued for a sufficient period of time (e.g. 1 week) ; (5) No serious or uncontrolled underlying diseases, clinical evaluation patients can tolerate puncture; (6) Planned biopsy with applicable puncture path; (7) With informed consent.
Exclusion Criteria:
(1)Biopsy needle insertion route impeded by skeletal structures and close to blood vessels which have high risks of puncture bleeding; (2)Poor organ function (e.g. poorly controlled high blood pressure); (3) Any contraindication of percutaneous head and neck biopsy; (4) Poor compliance, unable to complete coordination; (5) Participant who is considered inappropriate or unwilling to participate in this clinical trial for other reasons.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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3D-PCT group
Participant will receive three-dimensional printing co-planar template (3D-PCT) assisted CT-guided head and neck neoplasm biopsy and prospective accuracy and safety data will record.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Accuracy
Periodo de tiempo: During the operation.
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Depth and Angle difference between actual puncture and planned puncture pathway.
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During the operation.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Complication rate
Periodo de tiempo: During the first month after operation.
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Adverse event include needle track implantation metastasis and operation-related complications (e.g.
bleeding, nerve injury, air embolism).
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During the first month after operation.
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Pathological Diagnosis
Periodo de tiempo: During the first month after operation.
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The pathological diagnosis of head and neck biopsy.
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During the first month after operation.
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Procedural duration
Periodo de tiempo: During the operation.
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The length of procedural duration was measured from the time a patient lain on the examining bed of the CT scanner to the time the first CT scan post biopsy.
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During the operation.
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Radiation exposure
Periodo de tiempo: During the operation.
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Numbers of CT scan.
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During the operation.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Wang Junjie, Peking University Third Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Anticipado)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
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
- ChiECRCT20220052
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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