High-Resolution Microendoscopy to Guide Hysteroscopic Tumor Resection
Use of Fluorescence Imaging and High-Resolution Microendoscopy to Guide Hysteroscopic Tumor Resection in Patients With Endometrial Cancer
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tissue Collection and Imaging:
If participant is found to be eligible to take part in this study, during their standard-of-care hysterectomy, a tissue sample will be collected. This sample will be used for research and routine testing. Participant will sign a separate consent form for the hysterectomy.
During the hysterectomy, photographs of the tissue will be taken. Participant's private areas will be covered (as much as possible), and a picture of their face will not be taken.
A hysteroscopy will also be performed during participant's surgery. Participant's doctor will discuss the risks of the hysteroscopy with participant and they will be asked to sign a separate consent form. A hysteroscopy allows the doctor to look inside the uterus to see the tissue that is going to be collected for research imaging. This procedure is done with a tool called a hysteroscope, a long thin tube with a camera and a light. The hysteroscope will be inserted though the vagina and up into the uterus. An image will be displayed on a computer screen that is attached to the hysteroscope. The study doctor will use the image on the screen to look at different areas of the uterus to find the location and size of the tumor(s). This image may be recorded for future reference.
After the hysteroscopy, the study doctor will inject a contrast dye (Proflavine Hemisulfate) into participant's uterus to help the doctor see the lesions. A camera will then be used to photograph images of the uterus.
The tissue collection and the imaging will add about 45 minutes to participant's hysterectomy procedure.
Length of Study:
Patient's active participation in this study will be over after surgery.
Follow-Up Call:
About 30 days (+/-7 days) after the surgery, participant will be called and asked how they are doing.
This is an investigational study. The hysteroscope is commercially available and FDA approved for laparoscopic procedures. The use of the hysteroscope in this study is for research purposes only.
Proflavine Hemisulfate (contrast dye) is commercially available and FDA approved for treating umbilical cord stumps. Its use in this study is considered investigational.
Up to 20 participants will be enrolled in this study. All will take part at MD Anderson.
Tipo de estudio
Fase
- Fase 2
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Any patient with a confirmed preoperative diagnosis of endometrial cancer
- Histologic subtype limited to endometrioid adenocarcinoma
- Patients with any grade of endometrial cancer (histologically confirmed)
- Patients with no contraindications to surgery
- Patients scheduled for hysterectomy by laparotomy, laparoscopy, or robotic surgery
- Patient must have had a preoperative MRI within 30 days of surgery at MD Anderson Cancer Center. Outside imaging will be allowed provided that staff radiologist at MD Anderson consider the quality of the study optimal to make a definitive diagnosis regarding myometrial invasion
- Patients must have <50% myometrial invasion on preoperative MRI
- Patients must have disease confined to either anterior or posterior wall of the uterus
- Ability to understand and the willingness to sign a written Informed Consent Document (ICD).
Exclusion Criteria:
- Patients with invasive uterine disease (>50% invasion) by preoperative MRI
- Patients with a diagnosis of leiomyomata affecting the endometrium
- Patients with a prior history of endometrial ablation
- Patients with multifocal disease within the uterus on preoperative MRI
- Patients with polypoid tumors protruding through the endocervical canal
- Patients with histology other than endometrioid adenocarcinoma
- Patients who have undergone a prior D&C for diagnosis of endometrial cancer
- Patients with exposure to metformin within 6 months of endometrial cancer diagnosis or at the time of diagnosis
- Patients < 18 years of age
- Patients with a known allergy to proflavine or acriflavine
- Patients that are pregnant or nursing
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Hysteroscope Imaging
All patients entered in study will undergo cervical dilation after induction of general anesthesia.
Once the cervix has been dilated, a hysteroscope will be introduced in the uterine cavity to evaluate for presence of tumor.
Location and size of tumor documented.
White-light images obtained using the High-Resolution Microendoscopy (HRME) camera introduced through the hysteroscope.
Once completed; the hysteroscope will be removed and the uterine cavity will be infused with 10 mL of proflavine (an acridine dye) (0.01% Proflavine (10ml)).
A resectoscope will then be introduced in the uterine cavity and fluorescent images obtained using the HRME camera.
The resectoscope will then be used to remove all tumor as guided through HRME images.
The entire imaging and tumor resection process is estimated to take 45 minutes or less.
|
Once the cervix has been dilated, a hysteroscope will be introduced in the uterine cavity to evaluate for presence of tumor.
Location and size of tumor documented.
White-light images obtained using the HRME camera introduced through the hysteroscope.
Once completed; the hysteroscope will be removed and the uterine cavity will be infused with 10 mL of proflavine (an acridine dye) (0.01% Proflavine (10ml)).
A resectoscope will then be introduced in the uterine cavity and fluorescent images obtained using the HRME camera.
Otros nombres:
After hysteroscopy with HRME camera, uterine cavity infused with 10 mL of Proflavine.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Absence of Residual Disease in Hysterectomy Specimen
Periodo de tiempo: 1 day
|
Descriptive statistics used to summarize the expression in tumor tissue and in normal tissue for each of the molecular markers assessed, as well as the difference in tumor and normal tissue within patient.
Paired t-test used to compare the tumor and normal tissue with respect to the mean difference in expression of each marker, pairing tumor and normal tissue on patient.
Boxplots used to illustrate the distribution of the difference in expression in tumor and normal tissue for each marker.
|
1 day
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Pedro Ramirez, MD, M.D. Anderson Cancer Center
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes 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 (Estimar)
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
Otros números de identificación del estudio
- 2012-1080
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