Pilot Study of (61)CuATSM-PET Imaging in Cancer Patients

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EstadoTerminado

Patrocinadores

University of Wisconsin, Madison

ENSAYO CLÍNICO: NCT00585117

BioSeek: nct00585117

Palabras clave

Abstracto

Hypoxia is a key factor in malignant progression of a neoplasm. It is our aim to explore the basis for quantitative in vivo tumor imaging by Cu-61 diacetyl-bis(N4-methylthiosemicarbazone)PET imaging as a surrogate of tissue hypoxia. We hypothesize that the hypoxia levels are predictive of the tumor response to therapy. Patients will have 2 CU-ATSM PET scans done and the goal is to show spatially stable tracer distributions that correlate with tumor hypoxia. This study will serve as a pilot study for a PO1 submission

fechas

Verificado por última vez:	01/31/2012
Primero enviado:	12/20/2007
Inscripción estimada enviada:	12/20/2007
Publicado por primera vez:	01/02/2008
Última actualización enviada:	12/11/2019
Última actualización publicada:	12/12/2019
Fecha de inicio real del estudio:	11/30/2006
Fecha estimada de finalización primaria:	12/31/2011
Fecha estimada de finalización del estudio:	12/31/2011

Condición o enfermedad

CNS Brain Metastases

Head and Neck Cancer

Lung Cancer

Prostate Cancer

Esophageal Cancer

Intervención / tratamiento

Procedure: 1 CNS

Procedure: 2. Head and Neck

Procedure: 3. Lung

Procedure: 4. Prostate

Procedure: 5. Esophagus

Fase

Grupos de brazos

Brazo	Intervención / tratamiento
Experimental: 1 CNS imaging with CuATSM	Procedure: 1 CNS imaging with CuATSM
Experimental: 2. Head and Neck Imaging with CuATSM	Procedure: 2. Head and Neck Imaging with CuATSM
Experimental: 3. Lung imaging with CuATSM	Procedure: 3. Lung imaging with CuATSM
Experimental: 4. Prostate PET imaging with CuATSM	Procedure: 4. Prostate Imaging with CuATSM
Experimental: 5. Esophagus PET imaging with CuATSM	Procedure: 5. Esophagus Imaging with CuATSM

Criterio de elegibilidad

Edades elegibles para estudiar	18 Years A 18 Years
Sexos elegibles para estudiar	All
Acepta voluntarios saludables	si
Criterios	Inclusion Criteria: - Able to tolerated a PET/CT scan - Age 18 or older - Patient being considered for XRT for treatment of their cancer - Able to provide written informed consent Exclusion Criteria: - severe claustrophobia or inability to tolerate the PET scan - pregnant or breastfeeding women - Patients that need supplemental oxygen - Patients enrolled in experimental treatments

Salir

Medidas de resultado primarias

1. To validate the CuATSM-PET imaging by correlation to the serum level of osteopontin, a marker of hypoxia [end of study]

Medidas de resultado secundarias

1. To test reliability of the CuATSM uptake by quantifying the reproducibility of the pre-treatment CuATSM_PET scans [end of study]

2. To assess the technical and logistic feasibility of CuATSM-PET scans in a population of cancer patients [end of study]