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El ensayo clínico NCT07213154 para Neoplasia maligna de la piel, Skin Disorder, Neoplasia cutánea está reclutando. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí. | ||
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Universidad EmoryOptical Imaging Scans for the Diagnosis of Skin Cancer in Patients With Lesions 10 No invasivo
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT07213154 es un estudio intervencionista para Neoplasia maligna de la piel, Skin Disorder, Neoplasia cutánea. Su estado actual es: reclutando. El estudio se inició el 15 de octubre de 2025, con el objetivo de reclutar a 10 participantes. Dirigido por la Universidad Emory, se espera que finalice el 17 de septiembre de 2027. Los datos se actualizaron por última vez en ClinicalTrials.gov el 16 de diciembre de 2025.
Resumen
This clinical trial studies how well an optical imaging scan called quantitative oblique back-illumination microscopy (qOBM) helps in diagnosing skin cancer in patients with skin lesions. qOBM is a non-invasive procedure that uses red light for illumination, and may work better than no imaging procedures in aiding doctors in diagnosing skin lesions.
Descripción detallada
PRIMARY OBJECTIVE:
I. To perform a first-in-human study to assess the ability of a qOBM handheld device to reliably image skin pathology in-situ and in-vivo.
SECONDARY OBJECTIVES:
I. Characterize a wide variety of lesions including but limited to:
Ia. Malignant lesions: basal cell cancers, squamous cell cancers, Merkel cell cancer, melanoma, etc,; Ib. Non-malignant lesions: keloids, surgical scars, actinic kerato...
Mostrar másTítulo oficial
Assessment of Novel Label-free Optical Imaging Technology for the Evaluation of Skin Lesions
Condiciones médicas
Neoplasia maligna de la pielSkin DisorderNeoplasia cutáneaOtros ID del estudio
- STUDY00008502
- NCI-2025-02356 (Identificador de registro) (CTRP (Clinical Trial Reporting Program))
- STUDY00008502 (Otro identificador) (Emory University Hospital/Winship Cancer Institute)
- WINSHIP6407-24 (Otro identificador) (Emory University Hospital/Winship Cancer Institute)
- P30CA138292 (Subvención/contrato NIH (EE. UU.))
Número del NCT
Inicio del estudio (real)
2025-10-15
Última actualización
2025-12-16
Fecha de finalización (estimada)
2027-09-17
Inscripción (prevista)
10
Tipo de estudio
Intervencionista
FASE
N/A
Estado general
Reclutando
Objetivo principal
Diagnóstico
Método de asignación
No aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Ninguno (Abierto)
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
ExperimentalGroup I (qOBM) Patients who have skin melanoma and/or suspected dysplastic nevi undergo qOBM optical imaging scan on study. Patients may undergo 2 additional qOBM optical imaging scans at the discretion of the treating physician. After qOBM scans, patients who are diagnosed with skin cancer may proceed to Group II. | Quantitative Oblique Back-Illumination Microscopy Undergo qOBM |
ExperimentalGroup II (qOBM, SOC RT) GROUP II: Patients with skin cancer who are undergoing SOC RT undergo qOBM optical imaging scans prior to- and during or after SOC RT on study. Patients may also undergo qOBM optical imaging scans additional at approximately 1, 6, and 12 months after completion of SOC RT at the discretion of the treating physician. | Quantitative Oblique Back-Illumination Microscopy Undergo qOBM Terapia de radiación Undergo SOC RT |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
qOBM Clinical Assessment | Assessing the application of quantitative oblique back-illumination microscopy (qOBM) to assess skin pathology. Analysis will be descriptive in nature (e.g., appearance of cells in the epidermis, dermis, and basal junction). Quantitative analysis will include extracting image features such as mean, standard deviation, and kurtosis of the phase values; entropy, fractal dimension, gray level co-occurrence matrix, and other mathematical image features. Radiation Therapy Oncology Group (RTOG) Acute Radiation Morbidity Scoring Criteria (Skin) Grade 0. No change over baseline, Grade 1. Follicular, faint or dull erythema/epilation/dry desquamation/decreased sweating, Grade 2. Tender or bright erythema, patchy moist desquamation/moderate edema, Grade 3. Confluent, moist desquamation other than skin folds, pitting edema, Grade 4. Ulceration, hemorrhage, necrosis | Up to 12 months |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Usability of the qOBM Device | Will collect information regarding the usability of the device, including how ergonomic it is, ideal for factors for acquiring images and visualizing structures in real time. Quantitative analysis will include extracting image features such as mean, standard deviation, and kurtosis of the phase values; entropy, fractal dimension, gray level co-occurrence matrix, and other mathematical image features. Differences between similar diagnoses vs adjacent normal skin will be evaluated using a two-sided t-test. | Up to 12 months |
Asistente de participación
Criterios de elegibilidad
Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
- Male or Female
- Candidate with skin lesions
- Signed study-specific informed consent prior to study entry
- ≥ 18 years old
- Prior surgery or radiotherapy to the area to be treated
Universidad EmoryInstituto Nacional del Corazón, los Pulmones y la Sangre, Estados Unidos3019 estudios activos para explorarParte responsable del estudio
Mohammad K. Khan, Investigador principal, Principal Investigator, Emory University
Contactos centrales del estudio
Contacto: Mohammad K. Khan, MD, PhD, MS, FACRO, FACR, DABR, 404-778-3473, [email protected]
2 Centros del estudio en 1 países
Georgia
Emory University Hospital Midtown, Atlanta, Georgia, 30308, United States
Tiffaney Roundtree, Contacto, [email protected]
Mohammad K. Khan, MD, PhD, MS, FACRO, FACR, DABR, Investigador principal
Reclutando
Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, 30322, United States
Tiffaney K. Roundtree, Contacto, [email protected]
Mohammad K. Khan, MD, PhD, MS, FACRO, FACR, DABR, Investigador principal
Reclutando