Study to Evaluate the Effect of Age (Geriatric) and Kidney Function on the Safety, Efficacy and Pharmacokinetics of OctreoScan in Patients Who Have New or Recurrent Tumors
An Open-Label, Multi-Center, Phase 4 Study to Evaluate the Effect of Age (Geriatric) and Renal Function on the Safety, Efficacy (Sensitivity, Specificity) and Pharmacokinetics of OctreoScan in Patients Referred for Scintigraphy of All Solid Tumors With a High Suspicion of Containing Somatostatin Receptor Positive Tissue
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Tipo de estudio
Tipo de estudio
Inscripción (Actual)
Inscripción
Fase
Fase
- Fase 4
Contactos y Ubicaciones
Ubicaciones de estudio
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Florida
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Miami, Florida, Estados Unidos, 33136
- University of Miami, Jackson Memorial Hospital
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Iowa
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Iowa City, Iowa, Estados Unidos, 52242
- University of Iowa Medical Center
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Louisiana
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New Orleans, Louisiana, Estados Unidos, 70112
- Louisiana State University, Division of Hem/Onc
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- Hospital of University of Pennsylvania, Division of Nuclear Medicine
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-
Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Males or females 18 years of age and older.
- If female and of childbearing potential, patients must have a negative pregnancy test within 24 hours of study drug administration. In addition, all female patients of childbearing potential must agree to use a medically accepted method of contraception throughout the study.
- If deemed necessary by the Principal Investigator, patients entering the pharmacokinetic population must be willing to be housed within the investigational facility for a minimum of 24 hours following drug administration.
- Patients (when able) or legally authorized representatives must have the ability to understand the requirements of the study and provide written consent to participate and agree to abide by the study requirements.
- Patients must have tumor localization by conventional imaging methods prior to enrollment (i.e., CT, MRI, US, angiogram).
- Patients referred for scintigraphy of solid tumors with a high suspicion of containing somatostatin receptor positive tissue.
- Patients with first-time tumors must be scheduled for a tissue biopsy. A tissue sample will be sent to the core laboratory for conventional histology and immunohistochemistry analysis.
- Patients with recurrent tumors or progressive tumors must have previous biopsy results documented, with previous biopsy tissue obtainable for immunohistochemistry analysis.
Exclusion Criteria:
- Patients receiving Sandostatin LAR < 21 days prior to dosing or Sandostatin Immediate Release (IM) < 24 hours prior to dosing.
- Patients who have received any investigational drug within 30 days of admission into this study or plan to participate in a clinical study prior to the end of this study's monitoring period (patients on a research protocol using an approved drug are accepted).
- Patients who are pregnant, breastfeeding or lactating.
- Patients with a medical condition, serious intercurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up.
- Patients scheduled to undergo any scintigraphy within 7 days prior to study participation or PET scanning within 24 hours prior to study participation.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación factorial
- Enmascaramiento: Ninguno (etiqueta abierta)
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
|
Experimental: Group 1
Control, age greater than or equal to 18 with normal renal function
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Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
Otros nombres:
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Experimental: Group 2
Age 18 to less than 65 with mild renal impairment
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Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
Otros nombres:
|
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Experimental: Group 3
Age 18 to less than 65 with moderate to severe renal impairment
|
Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
Otros nombres:
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Experimental: Group 4
Age 18 to less than 65 with end stage renal impairment
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Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
Otros nombres:
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Experimental: Group 5
Age 65 to less than 75 with mild renal impairment
|
Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
Otros nombres:
|
|
Experimental: Group 6
Age 65 to less than 75 with moderate to severe renal impairment
|
Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
Otros nombres:
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Experimental: Group 7
Age 65 to less than 75 with end stage renal impairment
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Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
Otros nombres:
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|
Experimental: Group 8
Age greater than or equal to 75 with mild renal impairment
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Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
Otros nombres:
|
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Experimental: Group 9
Age greater than or equal to 75 with moderate to severe renal impairment
|
Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
Otros nombres:
|
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Experimental: Group 10
Age greater than or equal to 75 with end stage renal impairment
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Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Assessment of OctreoScan diagnostic sensitivity for detecting tumor(s) confirmed as somatostatin receptor positive by biopsy with immunohistochemistry analysis
Periodo de tiempo: Through 24 hours post dose
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Through 24 hours post dose
|
Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Assessment of OctreoScan diagnostic sensitivity for detecting tumor(s) confirmed as somatostatin receptor positive using previously biopsied tissue for immunohistochemistry analysis
Periodo de tiempo: Through 24 hours post dose
|
Through 24 hours post dose
|
Colaboradores e Investigadores
Patrocinador
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización primaria
Finalización del estudio (Actual)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- 0050-02-763
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