Identificación intraoperatoria de la glándula paratiroidea (PTG) utilizando un resumen de mano (HHI)
Estudio de viabilidad temprana sobre identificación intraoperatoria de la glándula paratiroidea (PTG) utilizando un resumen de mano (HHI)
It is often challenging to tell apart the parathyroid glands from the surrounding area such as lymph nodes, fat and thyroid tissue. If the surgeons are not able to tell where the parathyroid glands are, they might accidentally be removed or damaged. This can lead to complications such as hypocalcemia (low calcium level) requiring treatment and sometimes lead to longer hospital stay. This study is designed to test a new method (a non-invasive hand-held imaging device) to assist surgeons in identifying the parathyroid glands, in order to decrease the rate of post-operative complication.
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
In thyroid surgeries, it is often difficult to visually distinguish parathyroid glands (PTGs) from the surrounding anatomical structures in surgeries because of their small size and appearance that is similar to lymph nodes, fat, and thyroid tissue. Unfortunately, even with surgeons' abundant experience in thyroidectomies, unintentional injury or removal of PTGs is frequently identified due to the subjective and inconclusive localization of PTGs. Such accidental removal or injury of PTGs may lead to serious complications such as postoperative hypocalcemia or hypoparathyroidism. Therefore, there is a clear need to provide surgeons with intraoperative surgical guidance to safely identify PTGs in order to prevent the risk of surgical complications.
To meet this need, we aim to assess the ability of a new non-invasive, probe-based Hand-Held Imager (HHI) [hANDY-i, Optosurgical, LLC] to identify PTGs intraoperatively in order to help surgeons safely preserve PTGs in surgeries. Using Near-Infrared Autofluorescence Imaging (NIRAF), HHI's camera system will detect spontaneous autofluorescence signals without injection of any contrast. The probe component of the HHI will allow surgeons to conveniently and noninvasively navigate deeper areas where PTGs are difficult to reach. Should the HHI be able to discriminate PTGs from surrounding anatomical structures in the neck, the investigators hypothesize that surgeons will be better equipped to distinguish surgical margins of pathological tissue for safe resection in challenging thyroid surgeries.
Furthermore, in order to confirm the perfusion status of the PTGs indocyanine green (ICG) angiography imaging will be utilized in select cases where the blood supply deemed to be compromised, this will enable the surgeon to decide if the gland is still viable.
Tipo de estudio
Tipo de estudio
Inscripción (Actual)
Inscripción
Fase
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Maryland
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Baltimore, Maryland, Estados Unidos, 21287
- Johns Hopkins Hospital
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Diagnosis of thyroid tumors, or other conditions requiring thyroid surgery where frozen section biopsy of PTGs is deemed necessary under the surgeon's estimation.
- Plan for surgical resection of pathological PTGs.
- Subject age 18 - 70 yo.
- Subject agreement to participate
Exclusion Criteria:
- Not eligible for endocrine surgeries
- Plan for biopsy only of thyroid tumor (likely difficult to obtain sufficient tissue for both pathology analysis and study assessment)
- Subject age younger than 18 yo or older than 70 yo
- Subject refusal to participate
- Subject cognitively impaired and/or unable to provide assent.
- Allergy to indocyanine green and iodine.
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)
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
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Experimental: Parathyroid auto-florescence imaging
Patients undergoing open thyroid surgery |
All enrolled patients for thyroid surgery, once the thyroid gland is removed the device will be used to identify the parathyroid glands.
Otros nombres:
For a select group of patients when deemed necessary by the surgeon, and when one or more parathyroid gland appear to be de vascularized ICG will be administered, A dosage of 5 mg will be injected into a peripheral IV line, followed by fluorescence imaging to determine the perfusion status of the gland.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of Parathyroid Glands identified by the imager.
Periodo de tiempo: 10 minutes prior to injection of ICG
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Once the thyroid gland is removed the imager will be used to confirm the presence of 4 parathyroid glands, and will be compared to the number of parathyroid glands seen by naked eye. |
10 minutes prior to injection of ICG
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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Perfusion assessment using ICG angiography.
Periodo de tiempo: 10 minutes after ICG injection.
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ICG angiography will be done for some of the patients, who have signs of perfusion insufficiency, 2 mg of ICG will be administered and glands will be observed by the imager to confirm if the blood flow is intact. Assessment will be measured as: 0 - No signs of perfusion
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10 minutes after ICG injection.
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Measurement of Parathyroid hormone and calcium levels.
Periodo de tiempo: 1 day after the surgery.
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For all patients the levels of parathyroid hormone and calcium will measured pre and post operatively. |
1 day after the surgery.
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Colaboradores
Colaboradores
Investigadores
Investigadores
- Investigador principal: Kaitlyn Frazier, MD, Johns Hopkins University
Publicaciones y enlaces útiles
Publicaciones Generales
- Ali KM, Wolfe SA, Nagururu NV, Seo S, Han SM, Kim Y, Oh E, Kim DY, Ning B, Lee SY, Cha RJ, Tufano RP, Russell JO. Parathyroid gland detection using an intraoperative autofluorescence handheld imager - early feasibility study. Front Endocrinol (Lausanne). 2023 Jul 24;14:1190282. doi: 10.3389/fendo.2023.1190282. eCollection 2023.
- Kim Y, Lee HC, Kim J, Oh E, Yoo J, Ning B, Lee SY, Ali KM, Tufano RP, Russell JO, Cha J. A coaxial excitation, dual-red-green-blue/near-infrared paired imaging system toward computer-aided detection of parathyroid glands in situ and ex vivo. J Biophotonics. 2022 Aug;15(8):e202200008. doi: 10.1002/jbio.202200008. Epub 2022 Apr 20.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
Finalización primaria (Actual)
Finalización primaria
Finalización del estudio (Actual)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- IRB00224302
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Data review for each subject will be completed shortly after enrollment. The research data will not include the participant's contact or identifying information. Rather, individual participants and their research data will be identified by a unique study identification number. The study data entry and study management systems used by research staff will be secured and password protected. At the end of the study, all study databases will be archived at Johns Hopkins Hospital.
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.
producto fabricado y exportado desde los EE. UU.
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