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El ensayo clínico NCT06122610 para Tumores Neuroendocrinos, Tumor neuroendocrino positivo para el receptor de somatostatina 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 de Wisconsin-MadisonUsing Novel Imaging to More Safely Treat Neuroendocrine Tumors
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el ensayo' para ver y discutir la información del ensayo en el idioma que haya seleccionado.
El ensayo clínico NCT06122610 está diseñado para estudiar el tratamiento de Tumores Neuroendocrinos, Tumor neuroendocrino positivo para el receptor de somatostatina. Es un estudio intervencionista de Fase I. Su estado actual es: reclutando. El ensayo se inició el 7 de marzo de 2025, con el objetivo de reclutar a 10 participantes. Dirigido por la Universidad de Wisconsin-Madison, se espera que finalice el 1 de febrero de 2026. Los datos se actualizaron por última vez en ClinicalTrials.gov el 13 de mayo de 2025.
Resumen
The goal of this research is to determine if DetectnetTM PET/CT can be used to make Lutathera therapy safer for patients with neuroendocrine cancer.
Participants will:
- Complete two phases involving 6 visits
- Undergo additional research PET/CT, and possibly SPECT/CT scans
Descripción detallada
The goal of this research study is to determine if DetectnetTM PET/CT scanning over several days can be used to deliver Lutathera in a safer manner.
In this research, participants will be asked to complete a screening phase and possibly a dosimetry phase. The screening phase will require 2 visits. The dosimetry phase will also require 3 research visits.
Título oficial
Dosimetry-Guided 177Lu-DOTATATE Treatment Planning Using 64Cu-DOTATATE as a Surrogate
Condiciones médicas
Tumores NeuroendocrinosTumor neuroendocrino positivo para el receptor de somatostatinaOtros ID del ensayo
- 2023-0121
- Protocol Version 3/24/2025 (Otro identificador) (UW Madison)
- SMPH/RADIOLOGY/RADIOLOGY (Otro identificador) (UW Madison)
Número del NCT
Inicio del ensayo (real)
2025-03-07
Última actualización
2025-05-13
Fecha de finalización (estimada)
2026-02
Inscripción (prevista)
10
Tipo de estudio
Intervencionista
FASE
Fase I
Estado general
Reclutando
Palabras clave
neuroendocrine tumors
Objetivo principal
Tratamiento
Método de asignación
N/A
Modelo de intervención
Grupo único
Enmascaramiento
Ninguno (Etiqueta abierta)
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
ExperimentalParticipants treated with Lutathera | Single Photon Emission Computed Tomography/ Computed Tomography (SPECT/CT) SPECT/CT will be performed after first cycle of Lutathera® treatment Photon Emission Tomography / CT (PET/CT) PET/CT will be performed after 64Cu-DOTATATE and Lutathera® treatment 64Cu-Dotatate Standard of care administration of radioactive drug for PET/CT 177Lu-Dotatate Standard of care administration of radioactive drug for PET/CT and SPECT/CT |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Compare pre-therapy and post-therapy voxel-based dosimetry estimates | Absorbed doses to organs will be estimated using radiation dosimetry methods based on both multi-timepoint PET and multi-timepoint SPECT imaging. Mean dose estimates in units of Gy to the index tumor(s) and dose limiting organs (kidneys and bone marrow) will be compared between PET-based dosimetry and SPECT-based dosimetry. Using SPECT-based dosimetry as the gold standard truth, Bland-Altman analysis will be performed for each organ/tumor to compare PET-based dose estimates to SPECT-based estimates. Mean bias and 95% confidence intervals will be calculated. | Baseline and 120 hours post-dose |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Absorbed radiation doses | Absorbed radiation doses from 177Lu-DOTATATE in organs will be summarized with descriptive statistics. | 1 hour post-dose, 4 hours post-dose, 48 hours post-dose, 120 hours post-dose |
Absorbed radiation doses of 64Cu-DOTATATE | Absorbed radiation doses of 177Lu-DOTATATE in organs using 64Cu-DOTATATE as an imagining surrogate will be summarized with descriptive statistics. | 1 hour post-dose, 4 hours post-dose, 48 hours post-dose, 120 hours post-dose |
Compare 3D voxel-based versus model based dosimetry in participants receiving 177Lu_DOTATATE | Absorbed doses to organs will be estimated using radiation dosimetry methods based on multi-timepoint SPECT imaging. Mean dose estimates in units of Gy to the index tumor(s) and dose limiting organs (kidneys and bone marrow) will be compared between 3D voxel-based and model-based dosimetry methods. Using 3D voxel-based dosimetry as the gold standard truth, Bland-Altman analysis will be performed for each organ/tumor to compare 3D voxel-based to model-based methods. Mean bias and 95% confidence intervals will be calculated. | Baseline and 120 hours post-dose |
Criterios de elegibilidad
Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
- Candidates for 177Lu-DOTATATE (Lutathera) treatment for somatostatin receptor-positive neuroendocrine tumor
- Unable to lie flat during or tolerate PET/CT or SPECT/CT
- Known incompatibility to CT. SPECT, or PET scans
- Unlikely to comply with study procedures, restrictions and requirements and judged by the investigator that the participant is not suitable for participation in the study
Universidad de Wisconsin-Madison247 ensayos clínicos activos para explorarContactos centrales del ensayo
Contacto: Radiology Studies, 608-282-8349, [email protected]
1 Sitios del ensayo en 1 países
Wisconsin
University of Wisconsin - Madison, Madison, Wisconsin, 53705, United States
Reclutando