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GE-148-002: A Phase 2, Open-label, Single-Center Study to Assess GE-148 (18F) Injection PET Imaging to Detect Localized Prostate Cancer

21 de enero de 2014 actualizado por: GE Healthcare

GE148-002: A Phase 2, Open-label, Single-Center, Study to Assess GE-148 (18F) Injection Positron Emission Tomography(PET) Imaging to Detect Localized Prostate Cancer

Background:

- GE-148 (18F) is a new drug that is designed to attach to prostate cancer cells. Researchers are interested in combining the drug with a small amount of radioactive material to allow prostate cancer lesions to appear more clearly on imaging scans. Researchers are also interested in determining whether the combination can help make cancer cells in pelvic lymph nodes easier to detect through imaging studies. GE-148 (18F) will be used to examine individuals who are scheduled to have surgery on their prostate cancer.

Objectives:

- To evaluate the effectiveness of GE-148 (18F) in detecting prostate cancer and cancer cells in pelvic lymph nodes using positron emission tomography and magnetic resonance imaging scanning.

Eligibility:

- Men at least 18 years of age who have been diagnosed with prostate cancer and are scheduled to have prostate removal surgery.

Design:

  • Participants will be screened with a physical examination, medical history, blood tests, and imaging studies.
  • Participants will have magnetic resonance imaging (MRI) and positron emission tomography (PET) scans with GE-148 (18F) prior to their scheduled surgery. The MRI and PET scans may be performed on the same day or on different days, depending on the schedule set by the study researchers.
  • Tissue samples taken during prostate removal surgery, including prostate tissue and pelvic lymph nodes, will be collected for further study of the effectiveness of GE-148 (18F).

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Background:

  • Accurate imaging of prostate cancer is important for developing targeted minimally invasive therapies
  • GE-148 (18F) Injection is a drug product formulation known as [18F]FACBC which is a synthetic leucine amino acid analogue. Preliminary studies demonstrated efficacy in primary prostate cancer and metastatic/recurrent prostate cancers. We propose to evaluate GE-148 (18F) Injection as a PET radiopharmaceutical for the detection of prostate cancer.

Objectives: Primary Objective:

  • To differentiate the magnitude of uptake and retention of GE-148 (18F) Injection between malignant prostate tumors, non-malignant prostate pathology, and regions of normal prostate tissue in subjects with prostate cancer.
  • To assess the safety of a single dose of GE-148 (18F) Injection in subjects with prostate cancer.

Secondary Objectives:

  • To assess the relationship between the magnitude of uptake of GE-148 (18F) Injection with quantitative assessment of AAT expression in malignant prostate tumors, non-malignant prostate pathology, and regions of normal prostate tissue.
  • To assess the relationship between the magnitude of uptake of GE-148 (18F) Injection with quantitative assessment of Ki-67 expression in malignant prostate tumors, non-malignant prostate pathology, and regions of normal prostate tissue.
  • To assess the relationship between the magnitude of uptake of GE-148 (18F) Injection in malignant prostate tumors and their Gleason Score.
  • To assess the ability of GE-148 (18F) Injection to detect the number of discrete malignant prostate tumors confirmed by histopathology.
  • To assess the relationship between the magnitude of uptake of GE-148 (18F) Injection with quantitative measurement of AAT and Ki-67 expression in pelvic lymph nodes showing uptake of GE-148 (18F) Injection, where available.
  • To compare the ability of PET/CT imaging with GE-148 (18F) Injection to predict prostate malignancy and distinguish it from other pathologies (inflammation, hyperplasia, atrophy, hemorrhage) with that of T2W MRI, DCE MRI, MR DWI, and MRSI performed at 3T.

Eligibility:

  • Subject is 18 years old, ECOG 0-2, with documented prostate cancer (minimum 1 core).
  • Subject must be scheduled to undergo standard of care prostatectomy at NIH CC

Serum creatinine within 2 weeks prior to MRI less than or equal to1.8mg/dl, estimated GFR(eGFR) must be greater than 30 ml/min/1.73m2.

-Chemistry parameters: Aspartate aminotransferase (AST), Alanine transferase (ALT)2 x of the upper limits of normal; total bilirubin, of less than 2 x the upper limits of normal or less than 3.0 mg/dl in patients with Gilbert's syndrome.

Design:

Thirty subjects with localized prostate cancer scheduled for prostatectomy will undergo dynamic GE-148 (18F) Injection PET/CT imaging, and undergo a standard-of-care endorectal coil/pelvic multiparametric MRI . Results will be compared with pathology.

Tipo de estudio

Intervencionista

Inscripción (Actual)

25

Fase

  • Fase 2

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.

Ubicaciones de estudio

  • Estados Unidos
    • Maryland
      • Bethesda, Maryland, Estados Unidos, 20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

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

Masculino

Descripción

  • INCLUSION CRITERIA:
  • Subject is male and is greater than or equal to 18 years old.
  • Subject must be scheduled to undergo standard of care prostatectomy for presumed localized prostate cancer at the NIH Clinical Center.
  • Recent (within 12 months of study entry but not within 8-12 weeks before start of imaging study) prostate biopsy indicating the presence of adenocarcinoma of the prostate gland in which at least sextant biopsies were obtained.
  • Subjects must have a minimum of 1 positive-for-cancer biopsy core.
  • Serum creatinine within 2 weeks prior to MR imaging less than or equal to 1.8 mg/dl and eGFR must be greater than 30 ml/min/1.73m(2)
  • Chemistry parameters: AST and ALT 2 x of the upper limits of normal; total bilirubin, of less than or equal to 2 x the upper limits of normal or less than 3.0 mg/dl in patients with Gilbert's syndrome.
  • Eastern Cooperative Oncology Group (ECOG) Performance score of 0 to 2.
  • Ability to provide informed consent. All subjects must sign an informed consent form indicating their understanding of the investigational nature and risks of the study before any protocol-related studies are performed.
  • The subject has a clinically acceptable medical history, physical examination and vital signs findings during the screening period (from within 21 days before administration of GE-148 (18F) Injection).

EXCLUSION CRITERIA:

  • Known allergy to gadolinium.
  • Subjects for whom participating would significantly delay the scheduled standard of care therapy.
  • Subjects with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results.
  • Subjects with severe claustrophobia unresponsive to oral anxiolytics.

  • Subjects with contraindications to MRI

    • Subjects weighing more than 136 kg (weight limit for scanner table).
    • Subjects with pacemakers, cerebral aneurysm clips, shrapnel injury, or other implanted electronic devices or metal not compatible with MRI.

  • Subjects with contraindication to endorectal coil placement

    • Severe hemorrhoids.
    • Surgically absent rectum.
  • Other medical conditions deemed by the principle investigator (or associates) or sponsor to make the subject ineligible for protocol procedures.
  • Subjects who have previously received radiation therapy to the pelvis.
  • Subjects who have received androgen-deprivation therapy.
  • The subject has received, or is scheduled to receive, another IMP from 1 month before to 1 week after administration of GE-148 (18F) Injection.
  • Subjects with chronic renal failure (eGFR less than 30 ml/min/1.73m(2)).

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: No aleatorizado
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: GE 148-002
Droga: GE-148 (18F)
All subjects will receive an i.v. dose of GE-148 (18F) Injection at 10 mCi (370 MBq) to provide adequate image quality throughout the specified imaging period.
Otros nombres:
  • GE-148 (18F) Injection

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
To Assess the Magnitude of Uptake and Retention of GE-148 (18F) Injection in Malignant Prostate Tumors, Non-malignant Prostate Pathology, and Regions of Normal Prostate Tissue in Subjects With Prostate Cancer, Using PET/CT Imaging.
Periodo de tiempo: After GE-148 (18F) Injection administration.
Quantitative measurements of the level of uptake of GE-148 (18F) Injection into each tissue type (malignant prostate tumors, non-malignant prostate pathology, and regions of normal prostate) calculated as Standardized Uptake Values (SUVs), using histopathology as the standard of truth.
After GE-148 (18F) Injection administration.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
To Compare the Ability of PET/CT Imaging With GE-148 (18F) Injection to Predict Prostate Malignancy and Distinguish it From Other Pathologies (Inflammation, Hyperplasia, Atrophy, Hemorrhage) With That of T2W MRI, DCE MRI, MR DWI, and MRSI Performed at 3T.
Periodo de tiempo: After GE-148 (18F) Injection administration
Use of descriptive statistics to compare the ability of the PET/CT imaging and MRI to predict malignancy, based on histopathology as the standard of truth, on a subject basis and per lesion basis.
After GE-148 (18F) Injection administration

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

GE Healthcare

Colaboradores

National Cancer Institute (NCI)

Investigadores

  • Director de estudio: Paul Gordon, PhD, GE Healthcare

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

Enlaces Útiles

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

1 de julio de 2010

Finalización primaria (Actual)

1 de marzo de 2012

Finalización del estudio (Actual)

1 de marzo de 2012

Fechas de registro del estudio

Enviado por primera vez

5 de agosto de 2010

Primero enviado que cumplió con los criterios de control de calidad

5 de agosto de 2010

Publicado por primera vez (Estimar)

6 de agosto de 2010

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

14 de febrero de 2014

Última actualización enviada que cumplió con los criterios de control de calidad

21 de enero de 2014

Última verificación

1 de enero de 2014

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • GE-148-002
  • 10-C-0179

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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