A Project Assessing the Safety and Feasibility of Using Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Ovarian Cancer During Surgical Procedures
30 de octubre de 2026 actualizado por: Teresa Boitano, University of Alabama at Birmingham
Pilot Project Assessing the Safety and Feasibility of Using Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Ovarian Cancer During Surgical Procedures
This is a pilot project to determine the safety and feasibility of using panitumumab-IRDye800 to detect cancerous tissue compared to normal surrounding tissue in participants with ovarian cancer undergoing surgical resection. This study is an extension of the work previously done using this agent in patients with squamous cell carcinoma (SCC) of the head and neck, exploring its utility in a different cancer type.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
The study is an open label, single site, Phase I study to determine the safety and feasibility of using conjugated panitumumab-IRDye800 in patients with ovarian cancer undergoing surgical resection. Tumor to background ratios (TBRs) will be determined by comparing fluorescence intensity of tumor tissue to grossly normal tissue in the field. The presence of tumor tissue and fluorescence will be confirmed by histopathologic analysis.
Panitumumab-IRDye800CW has a toxicity and pharmacodynamic profile that matches the parent compound. In this study, patients will receive a 50mg flat dose of panitumumab-IRdye800 without a loading dose of panitumumab alone, which was found in the Phase I study of patient with head and neck cancer to be the safest and most cost-effective dose in a dose-range escalation study with high sensitivity, specificity, Positive Predictive Value (PPV), and Negative Predictive Value (NPV) for fluorescence detection of tumor compared to normal background tissue. This infusion will occur 24-72 hours prior to planned surgery.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
6
Fase
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Michelle Osoinak, BSN, RN, CNOR
- Número de teléfono: 205-539-2903
- Correo electrónico: mosoinak@uabmc.edu
Ubicaciones de estudio
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Alabama
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Birmingham, Alabama, Estados Unidos, 35233
- University of Alabama at Birmingham
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Sub-Investigador:
- Jason Warram, PhD
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Investigador principal:
- Teresa Boitano, MD
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Contacto:
- Michelle Osoinak, BSN, RN, CNOR
- Número de teléfono: 205-539-2903
- Correo electrónico: mosoinak@uabmc.edu
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Femenino
Descripción
Inclusion Criteria:
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Biopsy-confirmed diagnosis of ovarian cancer.
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Diagnosis of any stage.
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Diagnosis of any histology.
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Planning to undergo surgical resection via any modality (i.e., open, laparoscopic, robotic) with primary cytoreduction or interval debulking following neoadjuvant chemotherapy.
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Age ≥ 18 years
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ECOG 1
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Have acceptable hematologic status, coagulation status, kidney function, and liver function including the following clinical results:
- Hemoglobin ≥ 9 gm/dL
- Absolute Neutrophil Count ≥ 1500
- White Blood Cell count > 3000/mm3
- Platelet count ≥ 100,000/mm3
- Serum creatinine ≤ 1.5 times upper reference range
Exclusion Criteria:
- Received an investigational drug within 30 days prior to first dose of panitumumab-IRDye800
- Had within 6 months prior to enrollment: MI, CVA, or uncontrolled CHF
- History of infusion reactions to any monoclonal antibody therapies
- Pregnant or breast-feeding
- Evidence of QT prolongation on pretreatment EKG (greater than 440 ms in males or greater than 450 ms in females)
- Magnesium or potassium lower than the normal institutional values
- Patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
- Patients with a history or evidence of interstitial pneumonitis or pulmonary fibrosis
- TSH > 13 micro International Units/mL
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿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: Patients requiring surgical resection of ovarian cancer
Enrolled patients will receive a one-time IV infusion of 50mg of the investigational agent, panitumumab-IRDye800, 24-72 hours prior to the scheduled surgical resection. Participants will be monitored using standard clinical parameters to evaluate for toxicity. Participants will be observed immediately after infusion of the study drug. The following observations and tests shall be performed after treatment to identify both acute and late treatment specific toxicity: vital signs, physical exam, toxicity grading, assignment of performance status, hematology, and blood chemistries (complete metabolic profile to include magnesium and phosphorus). NCI Common Toxicity Criteria v5.0 will be used for grading of toxicity. |
Single IV systemic infusion of panitumumab-IRDye800 and NIR imaging of cancer during and after surgical resection. Enrolled patients will receive a one-time IV infusion of 50mg of the investigational agent, panitumumab-IRDye800, 24-72 hours prior to the scheduled surgical resection. All appropriate labs, tests, and safety monitoring will occur as outlined in Section 8.1. Participants will be monitored using standard clinical parameters to evaluate for toxicity. Participants will be observed immediately after infusion of the study drug. The following observations and tests shall be performed after treatment to identify both acute and late treatment specific toxicity: vital signs, physical exam, toxicity grading, assignment of performance status, hematology, and blood chemistries (complete metabolic profile to include magnesium and phosphorus). NCI Common Toxicity Criteria v5.0 will be used for grading of toxicity. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of Dose limiting toxicity (DLT)
Periodo de tiempo: up to 15 days after infusion
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Dose limiting toxicity (DLT) defined as any grade 2 or greater toxicity that is considered definitely related to the study drug, considered clinically significant by the Principal Investigator, and occurs within 15 days of receiving treatment. |
up to 15 days after infusion
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Teresa Boitano, MD, University of Alabama at Birmingham
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
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Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de noviembre de 2026
Finalización primaria (Estimado)
1 de noviembre de 2027
Finalización del estudio (Estimado)
1 de noviembre de 2027
Fechas de registro del estudio
Enviado por primera vez
30 de octubre de 2026
Primero enviado que cumplió con los criterios de control de calidad
30 de octubre de 2026
Publicado por primera vez (Actual)
5 de noviembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
5 de noviembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
30 de octubre de 2026
Última verificación
1 de octubre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- STUDY00000341
- UAB (Otro identificador: UAB)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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