Spanish
Albanian
Arabic
Armenian
Azerbaijani
Belarusian
Bengali
Bosnian
Catalan
Czech
Danish
Deutsch
Dutch
English
Estonian
Finnish
Français
Greek
Haitian Creole
Hebrew
Hindi
Hungarian
Icelandic
Indonesian
Irish
Italian
Japanese
Korean
Latvian
Lithuanian
Macedonian
Mongolian
Norwegian
Persian
Polish
Portuguese
Romanian
Russian
Serbian
Slovak
Slovenian
Spanish
Swahili
Swedish
Turkish
Ukrainian
Vietnamese
Български
中文(简体)
中文(繁體)

Robot-Assisted MRI-Guided Prostate Biopsy

Solo los usuarios registrados pueden traducir artículos
Iniciar sesión Registrarse
El enlace se guarda en el portapapeles.
EstadoTerminado
Patrocinadores
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Colaboradores
National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Palabras clave

Abstracto

Prostate biopsies are commonly performed freehanded under transrectal ultrasound guidance (TRUS). Due to the manual approach and the limitations of the ultrasound imager, the procedure has high false-negative rates. This represents a daily problem for urologists managing the disease, creates uncertainty and emotional stress for patients, and initiates a cascade of repeat testing and biopsies which also burden the investigators healthcare system.
The investigators believe that prostate biopsy can be improved by using a new biopsy paradigm. The investigators plan to perform MRI-guided prostate biopsies with robot-assistance for orienting a needle-guide through which the biopsy is taken. The combination of MRI and robotic precision is expected to improve prostate biopsy sensitivity compared to regular TRUS biopsies.
The study is a Pilot clinical trial on 5 patients to primarily assess feasibility and safety. The needle-guide robot is an investigational device developed in their Urology Robotics Laboratory.

Descripción

While prostate cancer is the most common non-dermatologic malignancy among men in the US, it is frequently indolent and may not require radical therapy, i.e. radical prostatectomy or external beam radiotherapy. There has been increased interest in conservative approaches to low risk disease, including both active surveillance and focal therapy. Both of these approaches require accurate mapping of the prostate to allow for reproducible access to diseased portions of the gland, for biopsy or treatment purposes. Magnetic resonance imaging (MRI) has been increasingly utilized for prostate cancer staging and is considered the most accurate technique available for imaging prostate cancer. Furthermore there is increasing concern about the use of freehand transrectal ultrasound (TRUS) and needle biopsying in terms of reproducibility and accuracy in mapping disease. With systematic TRUS-guided biopsy the sensitivity of the test is low (33%-44%) and yields high false-negative rates (23%) [1, 2].

The investigators hypothesize that the integration of a novel robotic device for assisting MRI-guided prostate biopsy is feasible, safe, and accurate. This represents the first clinical trial of robotic assistance for MRI-guided transperineal prostate biopsy. The device consists of a robotic needle-guide instrument developed in the investigators Urology Robotics Laboratory. The robot orients a needle-guide on target based on MRI. The physician verifies the alignment and manually takes the biopsy, as usual. Pre-clinical tests showed that the robot operates precisely and safely in the MRI scanner and does not deteriorate imaging quality.

fechas

Verificado por última vez: 12/31/2018
Primero enviado: 02/05/2014
Inscripción estimada enviada: 03/03/2014
Publicado por primera vez: 03/05/2014
Última actualización enviada: 01/09/2019
Última actualización publicada: 01/13/2019
Fecha de inicio real del estudio: 07/24/2013
Fecha estimada de finalización primaria: 12/31/2015
Fecha estimada de finalización del estudio: 12/31/2015

Condición o enfermedad

Prostate Cancer

Intervención / tratamiento

Device: Robot-assisted prostate biopsy

Fase

-

Grupos de brazos

BrazoIntervención / tratamiento
Experimental: Robot-assisted prostate biopsy
Device: Robot-assisted prostate biopsy

Criterio de elegibilidad

Edades elegibles para estudiar 35 Years A 35 Years
Sexos elegibles para estudiarMale
Acepta voluntarios saludablessi
Criterios

Inclusion Criteria:

- men between the ages of 35 and 75,

- have a negative 12 core prostate biopsy, and

- must have one of the following "high risk" features:

- PSA >= 5.0 ng/ml and Prostate Volume <= 50cc,

- PSA density >= 0.2ng/ml/cc,

- Percent Free PSA <=10%,

- PSA velocity > 0.5 ng/ml/year,

- High Grade Prostate Intraepithelial Neoplasia on previous biopsy, or Atypia on previous biopsy.

Exclusion Criteria:

- bleeding problems,

- metal implants precluding MRI scanning,

- previous rectal surgery, anal stenosis that precludes endorectal coil insertion,

- patients who cannot tolerate anesthesia or in whom anesthesia is considered high-risk, and

- patients who are unwilling or unable to sign informed consent.

Salir

Medidas de resultado primarias

1. Number of participants with adverse events [Three months]

2. Logged unsuccessful attempts to target prostate [1 year]

3. Time for device setup, image registration, MRI time, biopsy sampling [1 year]

4. Score for operation of the device [1 year]

Score assigned by the engineers on a 1 to 5 scale

5. Score for image deterioration [1 year]

Score assigned by radiologist on image quality on a 1 to 5 scale

6. Quality of the obtained biopsy specimen [1 year]

Score assigned by the pathologist on a 1-5 scale.

7. Overall grade of the device and procedure [1 year]

Grade give by urologist, radiologist and anesthesiologist on a 1-5 scale.

Medidas de resultado secundarias

1. Distance from the collected to planned biopsy core center measured on DICOM [One year]

2. Number of needle trajectory corrections needed for alignment of each biopsy core [1 year]

3. Number of diagnosed prostate cancers [1 year]

4. Number of positive/total cores for each patient [1 year]

5. Correlation of pathology findings with cancer specific region (CSR)s on MRI [1 year]

Únete a nuestra
página de facebook

La base de datos de hierbas medicinales más completa respaldada por la ciencia

  • Funciona en 55 idiomas
  • Curas a base de hierbas respaldadas por la ciencia
  • Reconocimiento de hierbas por imagen
  • Mapa GPS interactivo: etiquete hierbas en la ubicación (próximamente)
  • Leer publicaciones científicas relacionadas con su búsqueda
  • Buscar hierbas medicinales por sus efectos.
  • Organice sus intereses y manténgase al día con las noticias de investigación, ensayos clínicos y patentes.

Escriba un síntoma o una enfermedad y lea acerca de las hierbas que podrían ayudar, escriba una hierba y vea las enfermedades y los síntomas contra los que se usa.
* Toda la información se basa en investigaciones científicas publicadas.

Google Play badgeApp Store badge