A Comparison of [68Ga]DOTATATE and [18F]AmBF3TATE for the Staging and Assessment of Neuroendocrine Malignancies (NET-COMPARE)
A Prospective and Head-to-head Comparison of [68Ga] Ga-DOTATATE and [18F]AmBF3TATE for the Staging and Assessment of Neuroendocrine Malignancies: NET-COMPARE Study
Neuroendocrine tumours (NETs) are generally slow growing, but some can be aggressive and resistant to treatment. Compared to healthy cells, the surface of these tumor cells has a greater number of molecules called somatostatin receptors (SSTR) which requires specific PET scan tracers to sufficiently capture on images. The current standard of care tracer at BC Cancer for SSTRs on NETs is 68Ga-DOTATATE. This project seeks to identify if 18F-AmBF3-TATE (a tracer that has established safety from phase 1 trial results), is comparable in disease detection, no. of lesions identified, image quality, safety and overall accuracy, to 68Ga-DOTATATE.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Research Project Manager
- Número de teléfono: 7649 604-675-8000
- Correo electrónico: MITclinicaltrials@bccancer.bc.ca
Copia de seguridad de contactos de estudio
- Nombre: Administrative Research Manager
- Número de teléfono: 2818 604-877-6000
- Correo electrónico: MITclinicaltrials@bccancer.bc.ca
Ubicaciones de estudio
-
-
British Columbia
-
Vancouver, British Columbia, Canadá, V5Z 4E6
- BC Cancer Vancouver
-
Contacto:
- Pavithraa Ravi
- Número de teléfono: 2818 6048776000
- Correo electrónico: pavithraa.ravi@bccancer.bc.ca
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
This will be a prospective, open-label trial in patients with suspected or proven SSTR positive tumors.
Descripción
Inclusion Criteria:
- Age ≥18 years
- Patients referred for and meeting institutional criteria for a [68Ga]DOTATATE PET/CT for the investigation of a known or suspected neuroendocrine malignancy (BC Cancer criteria APPENDIX A).
Exclusion Criteria:
- Pregnant and breast-feeding patients.
- Patients unwilling or unable to undergo a second PET/CT.
- Patients exceeding the safe weight limit of the scanner (204.5 kg) or who cannot fit through the PET/CT bore (70cm diameter).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
PET/CT Diagnostic Imaging
Each subject will have two PET/CT scans, one using 68Ga-DOTATATE and the other using 18F-AmBF3-TATE. The 18F-AmBF3-TATE radioactive tracer is manufactured for this study under a Clinical Trial Application filed with Health Canada. 68Ga-DOTATATE is considered standard care and has been approved by Health Canada. |
Each study participant will have an intravenous catheter inserted. The participant will receive a bolus intravenous dose of the standard of care tracer 68Ga-DOTATATE from an approved study supplier site. After a 60 minute uptake phase, the participant will then be taken to a designated washroom and asked to void prior to being scanned in order to clear excreted radiotracer activity from the urinary tract. Participants are positioned supine, arms down, and centered on the scanner bed and the PET/CT images will be acquired. Each study participant will have an intravenous catheter inserted. The participant will receive a bolus intravenous dose of the investigational tracer 18F-AmBF3-TATE from an approved study supplier site. After a 60 minute uptake phase, the participant will then be taken to a designated washroom and asked to void prior to being scanned in order to clear excreted radiotracer activity from the urinary tract. Participants are positioned supine, arms down, and centered on the scanner bed and the PET/CT images will be acquired. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of lesions detected by [18F]AmBF3TATE compared to [68Ga]DOTATATE
Periodo de tiempo: Periprocedural
|
To assess the non-inferiority of [18F]AmBF3TATE compared to the standard-of-care [68Ga]DOTATATE |
Periprocedural
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of patients in whom one or more target lesions are detected by the core readers.
Periodo de tiempo: within 2 weeks of the scan
|
Number of patients in whom [18F]AmBF3TATE and [68Ga]DOTATATE detects disease. |
within 2 weeks of the scan
|
|
Standard Uptake Values (SUV) for lesions detected
Periodo de tiempo: within 2 weeks of the scan
|
To assess uptake values (SUV) for tumour lesions (SUVmax, SUVpeak, tumour to background ratio for liver, blood, kidney and lung, contrast and signal to noise ratio). |
within 2 weeks of the scan
|
|
CNR (contrast to noise ratio), TBR (tumor tissue to background tissue ratio), Tumor/blood; Tumor/Liver; Tumor/ kidney; tumor/lung, Likert scale for reader quality assessment
Periodo de tiempo: within 2 weeks of the scan
|
To assess image quality using semi-quantitative (contrast-to-noise and tumour-to-background) and subjective indices |
within 2 weeks of the scan
|
|
Diagnostic confidence on a three-point scale (high, moderate and low), Fleiss' Kappa to measure inter-rater agreement
Periodo de tiempo: within 2 weeks of the scan
|
To assess reader confidence and inter-rater agreement |
within 2 weeks of the scan
|
|
Frequency of adverse events (AE) and serious adverse events (SAE).
Periodo de tiempo: Immediately post-scan
|
To compare the safety of both tracers |
Immediately post-scan
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ian Alberts, MBBS MD PhD FEBNM, BC Cancer
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
Términos MeSH relevantes adicionales
- Neoplasias
- Neoplasias por tipo histológico
- Neoplasias Glandulares y Epiteliales
- Adenocarcinoma
- Carcinoma
- Tumores neuroectodérmicos
- Neoplasias De Células Germinales Y Embrionarias
- Neoplasias De Tejido Nervioso
- Neoplasias ductales, lobulillares y medulares
- Carcinoma Neuroendocrino
- Feocromocitoma
- Tumores neuroendocrinos
- Paraganglioma
- Carcinoma Medular
Otros números de identificación del estudio
- H26-00640
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .