- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02000778
EC17 for Intraoperative Imaging in Occult Ovarian Cancer
A Pilot & Feasibility Study of the Imaging Potential of EC17 in Subjects Undergoing Intraoperative Detection of Occult Ovarian Carcinoma
The overall prevalence of Ovarian Cancer in the United States according to the US SEER Registry is 182,710 women. Ovarian cancer also has the highest mortality rate of the gynecological cancers. The overall five-year survival rate is 45% and for Stages III and IV it is only 20-25%. The majority of these are aged 50 years or older, but a few girls less than 10 years of age have been diagnosed with ovarian cancer. This risk increases with age and decreases with numbers of pregnancies.
The prognosis for many carcinomas is dependent on the extent of surgical resection. At present, the ability to perform a complete resection with negative margins is limited by the investigator's ability to palpate and visualize the tumor and its borders. In many cases, a more radical resection than necessary is performed in order to provide assurance that negative margins are achieved. This approach may also increase complication rates, as well as short- and long-term morbidity. It is desirable to improve visualization of primary tumors and occult metastases in real time, during surgery. The use of fluorescent probes that recognize cancer-specific antigens, in conjunction with a clinical imaging system, is under investigation.
Ovarian cancer is a prototypic disease for this type of clinical imaging system called intra-operative imaging. Except in Stage IV, the tumors are confined to the pelvis or abdomen and typically involve extensions or implants onto pelvic or abdominal organs or membranes. Tumor debulking surgery is common early in the disease process as many of the tumors can be identified by appearance or feel in the skilled surgeon's hands. The major problems are that tumors can be diffuse and numerous, of various sizes, and often not readily visible in the surgical field.
Over 90-95% of serous ovarian cancers express folate receptor (FR)-alpha, making this receptor an ideal target for marking most ovarian cancers. Folate is the prototypic agonist at the FR-alpha with potential uses for imaging and targeted therapeutic strategies.Chemotherapy does not affect FR-alpha expression in ovarian cancer specimens examined by immunohistochemistry, so prior treatment is unlikely to affect utility of FR-alpha agonists as imaging or therapeutic agents.
Descripción general del estudio
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- Hospital of the University of Pennsylvania
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Female subjects 18 years of age and older
- Female subjects of childbearing potential or less than 2 years postmenopausal agree to receive a urinary or serum beta HCG test prior to subject enrollment. Documentation must be acquired for women of menopausal or post-menopausal status prior to subject enrollment if they are below the age of sixty (60).
Primary diagnosis, or at high clinical suspicion, of primary ovarian cancer:
- Patient is scheduled to undergo laparotomy OR
- Patient is scheduled to undergo laparoscopy then pre-authorized laparotomy if cancer is found.
Exclusion Criteria:
1. Known sarcomatous histologies
- Recurrent ovarian cancer
- Known FR-alpha negative cancer
- Planned surgical approach via laparoscopy or robotic (no intention to perform laparotomy)
- History of anaphylactic reactions to Folate-FITC (EC17) or insects
- Pregnancy
- Brain metastases
- Taking compounds that inhibit active transport of organic anions (probenecid)
- Hepatic impairment, as evidenced by greater than 3x the upper limit of normal (ULN) for ALT, AST, or total bilirubin (except for known cases of Gilbert's syndrome), or renal impairment, as evidenced by greater than 1.5x the ULN for BUN or creatinine
- Received study agent in another investigational drug or vaccine trial prior to surgery
At-risk patient populations
- People who would easily be lost to follow up (ex: People who are homeless or alcohol dependent)
- Patients unable to participate in the consent process (children and neonates)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Grupo de inyección EC17
El grupo recibirá una dosis única de EC17, infundida durante 10 minutos, antes de la cirugía.
Luego, durante la cirugía, se tomarán imágenes del EC-17 con una cámara que los investigadores han desarrollado.
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Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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La capacidad de EC17 y el sistema de formación de imágenes para detectar tumores positivos para FRA durante la cirugía se llevó a cabo de 2 a 4 horas después de la administración de EC-17.
Periodo de tiempo: Dentro de dos a cuatro horas de la inyección de EC17
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Dentro de dos a cuatro horas de la inyección de EC17
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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The number of participants that will have an adverse reaction to the EC17
Periodo de tiempo: Day 1-Day 30
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Day 1-Day 30
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Sunil Singhal, University of Pennsylvania
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
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
Palabras clave
Términos MeSH relevantes adicionales
- Neoplasias por tipo histológico
- Neoplasias
- Neoplasias urogenitales
- Neoplasias por sitio
- Carcinoma
- Neoplasias Glandulares y Epiteliales
- Neoplasias Genitales Femeninas
- Enfermedades del sistema endocrino
- Enfermedades Ováricas
- Enfermedades anexiales
- Trastornos gonadales
- Neoplasias de glándulas endocrinas
- Neoplasias Ováricas
- Carcinoma Epitelial De Ovario
Otros números de identificación del estudio
- 818533
- 818533 [UPenn IRB Protocol #]
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. .
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