EC17 for Intraoperative Imaging for Parathyroidectomy
Palabras clave
Abstracto
fechas
Verificado por última vez: | 05/31/2018 |
Primero enviado: | 11/20/2013 |
Inscripción estimada enviada: | 11/25/2013 |
Publicado por primera vez: | 11/26/2013 |
Última actualización enviada: | 06/28/2018 |
Última actualización publicada: | 07/02/2018 |
Fecha de inicio real del estudio: | 10/31/2013 |
Fecha estimada de finalización primaria: | 08/31/2014 |
Fecha estimada de finalización del estudio: | 08/31/2014 |
Condición o enfermedad
Intervención / tratamiento
Drug: EC17 Injection Group
Fase
Grupos de brazos
Brazo | Intervención / tratamiento |
---|---|
Experimental: EC17 Injection Group The group will receive a single dose of EC17, infused over 10 minutes, prior to surgery. Then, during surgery, the EC-17 will be imaged with a camera that the investigators have developed. | Drug: EC17 Injection Group |
Criterio de elegibilidad
Edades elegibles para estudiar | 18 Years A 18 Years |
Sexos elegibles para estudiar | All |
Acepta voluntarios saludables | si |
Criterios | Inclusion Criteria: 1. Adult patients over 18 years of age 2. Patients presenting with primary hyperparathyroidism presumed to be resectable on pre-operative assessment 3. Good operative candidate 4. Subject capable of giving informed consent and participating in the process of consent. Exclusion Criteria: 1. Pregnant women as determined by urinary or serum beta hCG within 72 hours of surgery 2. Patients with a history of anaphylactic reactions to Folate-FITC or insects 3. Vulnerable patient populations 1. Homeless patients 2. Patients with drug or alcohol dependence 3. Children and neonates 4. Patients unable to participate in the consent process |
Salir
Medidas de resultado primarias
1. The ability of EC17 and the imaging system to detect FRA positive tumors during surgery conducted 2-4 hours post EC-17 administration. [Within two to four hours of injection of EC17]
Medidas de resultado secundarias
1. The number of participants that will have an adverse reaction to EC17 [Day 1-Day 30]