- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00082147
Magnetic Resonance Imaging to Locate and Characterize Prostate Cancer
A Prospective Histopathologic Study of Dynamic Contrast Enhanced MRI for Prostate Cancer Delineation and Characterization With the APT-MRI System
This study will examine the usefulness of an imaging procedure called dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) for localizing and characterizing prostate cancer. For this test, a medicine is injected into a vein and the MRI measures how the medicine flows through the prostate gland. The measurements provide information about the blood vessels in the prostate gland, which provides other information about the cancer. Several needle biopsies are performed during the procedure, and the results of the biopsies are compared with the information from the DCE-MRI.
Men 18 years of age and older with suspected or confirmed prostate cancer may be eligible for this study. Candidates are screened with a medical history and physical examination, blood test, and review of tumor pathology.
Participants undergo DCE-MRI and needle biopsies of the prostate. The day before and the morning of the procedure, patients are given an antibiotic called Levofloxacin. They also have a small enema the morning of the test. A local anesthetic is then given in the area around the prostate to numb the tissue and decrease any discomfort from the procedure. A tube is placed in the rectum to obtain better pictures of the prostate gland during the imaging. During the scan, the patient may be asked to breathe air that contains higher concentrations of oxygen and carbon dioxide than are in room air. The MRI scans guide the physician in selecting areas of the prostate to biopsy. For each biopsy, a needle is placed through the rectum into the prostate gland. When the needle is in place, a small tissue sample is withdrawn. This procedure is repeated until 4 to 10 biopsies are taken. During the procedure, which lasts about 1 hour, the patient lies on his stomach on a stretcher.
Patients who are planning to undergo surgery or radiation treatment for their cancer at the NCI may have up to four 1-mm non-reactive gold markers placed in the prostate during the DCE-MRI procedure. The markers are left in place to help target the radiation treatments and to show where the biopsies were taken if the prostate is removed.
At the end of the procedure, the patient is moved to a bed to recover and may get up and urinate after about 30 to 60 minutes. After a period of observation, the patient is discharged home with a dose of antibiotic to take the next day.
Some patients may be asked to repeat the MRI and biopsy procedure during or after their treatment for prostate cancer to help investigators learn whether the MRI test is still helpful after treatment. Repeat testing is optional.
Descripción general del estudio
Descripción detallada
Accurate spatial delineation and biologic characterization of tumors within the prostate gland by non-invasive means, such as MR imaging, stands to impact the spectrum of prostate cancer care. At present there are no imaging techniques that can accurately delineate tumor extent. With dynamic contrast enhanced MRI (DCE-MRI), signal intensity can be plotted over time for various regions of interest within the prostate, and reflect physiological parameters such as tissue perfusion, blood flow, vascular density and vascular permeability. Preliminary studies suggest that malignant tumors demonstrate a more rapid and intense uptake of contrast, as well as a more rapid washout compared with the normal peripheral zone. However, histopathologic confirmation of these findings has been limited.
This study strives to establish a correlation between K(trans) calculated from DCE-MRI data and the corresponding tissue histopathology. This will be achieved by acquiring needle biopsies with the APT-MRI (Access to Prostate Tissue under MRI-guidance) system in accurate spatial and temporal reference to DCE-MR images. The study will accrue 80 patients over a 2-year period with the primary analysis relating K(trans) to the probability of malignancy using Generalized Estimating Equations.
Patients who have undergone a TRUS-guided biopsy for suspected prostate cancer or patients with a pathological diagnosis of prostate cancer will be potential candidates for enrollment. Prior to the procedure, blood will be drawn and urine collected to measure PSA level and for protein profiling. Patients will then undergo endorectal coil MR imaging of the prostate gland, including conventional anatomic imaging and dynamic-contrast-enhanced MRI. During MR imaging, 4 to 10 needle biopsy cores of the prostate will be obtained using a trans-rectal needle guide system (APT-MRI). The ability to obtain prostate biopsy cores from all prostatic subzones and sites of interest will be documented, as will the overall procedure time and acute toxicities associated with the procedure. Histopathology and laboratory results of needle core biopsies will be compared to corresponding DCE-MRI measurements, prior TRUS-biopsy results, and/or prostatectomy specimens. This procedure may be repeated at a later time through the patient's course of observation, therapy, or follow up.
This is not a therapeutic trial. Patients admitted to this protocol will only be admitted to other protocols of experimental treatments if they also specifically meet the eligibility criteria for those protocols. Patients may derive benefit from the MRI-guided biopsy, which will be stated in the protocol consent document.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Maryland
-
Bethesda, Maryland, Estados Unidos, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
- INCLUSION CRITERIA:
- ECOG performance status 0 or 1.
- Patients with a TRUS-guided biopsy for suspected prostate cancer in the past twelve months, or patients with pathologically confirmed adenocarcinoma of the prostate gland and who have not received definitive local therapy.
- Age greater than or equal to 18 years.
- Informed consent: All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed.
EXCLUSION CRITERIA:
- Contraindication to trans-rectal biopsy:
- Bleeding disorder;
- PT/PTT greater than or equal to 1.5 times the upper limit of normal;
- Platelets less than or equal to 50K;
- Active anticoagulation;
- Severe immunocompromise;
- Severe hemorrhoids;
- Surgically absent rectum.
- Contraindication to MRI:
- Patients weighing greater than 136 kgs (weight limit for the scanner tables);
- Allergy to MR contrast agent;
- Patients with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable electronic devices not compatible with MRI.
- Allergy to local anesthetics or quinolone antibiotics.
- Patients with a known diagnosis of prostate cancer and a known treatment plan to proceed to prostatectomy if the result of the biopsy would not affect surgical management.
- Other medical conditions deemed by the PI or associates to make the patient ineligible for protocol procedures.
Plan de estudios
¿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 |
---|---|
Experimental: Biopsy
|
Patients will then undergo endorectal coil MR imaging of the prostate gland, including conventional anatomic imaging and dynamic-contrast-enhanced MRI During MR imaging, 4 to 10 needle biopsy cores of the prostate will be obtained using a trans-rectal needle guide system (APT-MRI).
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Correlation between the DCE-MRI kinetic parameter Ktrans and histopathologic determination of malignancy at corresponding biopsy sites within the prostate gland.
Periodo de tiempo: Post procedure
|
Post procedure
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
To further determine the feasibility and tolerability of MRI-guided prostate biopsy with the APTMRI system.
Periodo de tiempo: completion of study
|
completion of study
|
To determine the ability of the APT-MRI system to target all prostatic subzones and all sites suspicious of malignancy within the prostate gland.
Periodo de tiempo: completion of study
|
completion of study
|
To obtain further data on the tissue targeting accuracy of the APT-MRI system for needle biopsy
Periodo de tiempo: completion of study
|
completion of study
|
To determine if other DCE-MRI contrast kinetic parameters (Vf, amplitude, slope, and time to peak) correlate with the histopathologic determination of malignancy based on MRI-guided needle biopsies of the prostate gland.
Periodo de tiempo: completion of study
|
completion of study
|
To determine if the subjective determination of malignant sites within the prostate gland based on DCE-MR images, T2W images, or both, correlates with the histopathologic determination of malignancy based on MRI-guided needle biopsies.
Periodo de tiempo: completion of study
|
completion of study
|
To compare DCE-MRI data with the microvessel density of corresponding tissues.
Periodo de tiempo: completion of study
|
completion of study
|
1.1.2.7 To compare DCE-MRI data with the microarray and proteomic profiles of corresponding tissues.
Periodo de tiempo: completion of study
|
completion of study
|
To compare the histopathologic diagnosis and Gleason grade obtained with MRI-guided biopsies with prior TRUS-guided biopsy results.
Periodo de tiempo: completion of study
|
completion of study
|
To compare the Gleason grade of MR-guided biopsies with the Gleason grade of prostatectomy specimens.
Periodo de tiempo: completion of study
|
completion of study
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Steineck G, Helgesen F, Adolfsson J, Dickman PW, Johansson JE, Norlen BJ, Holmberg L; Scandinavian Prostatic Cancer Group Study Number 4. Quality of life after radical prostatectomy or watchful waiting. N Engl J Med. 2002 Sep 12;347(11):790-6. doi: 10.1056/NEJMoa021483.
- Potosky AL, Legler J, Albertsen PC, Stanford JL, Gilliland FD, Hamilton AS, Eley JW, Stephenson RA, Harlan LC. Health outcomes after prostatectomy or radiotherapy for prostate cancer: results from the Prostate Cancer Outcomes Study. J Natl Cancer Inst. 2000 Oct 4;92(19):1582-92. doi: 10.1093/jnci/92.19.1582.
- Rabbani F, Stroumbakis N, Kava BR, Cookson MS, Fair WR. Incidence and clinical significance of false-negative sextant prostate biopsies. J Urol. 1998 Apr;159(4):1247-50.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Actual)
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
- 040171
- 04-C-0171
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. .
Ensayos clínicos sobre Cancer de prostata
-
Abramson Cancer Center of the University of PennsylvaniaTerminadoPaciente con cancerEstados Unidos
-
Peking Union Medical College HospitalTerminadoEncuesta | Estado nutricional | Paciente con cancerPorcelana
-
Ankara Medipol UniversityReclutamientoCuidados personales | Inmunoterapia | Manejo de síntomas | Paciente con cancerPavo
-
Northwestern UniversityGenzyme, a Sanofi CompanyRetiradoCANCER DE PROSTATAEstados Unidos
-
Fundacao ChampalimaudTerminado
-
University College London HospitalsTerminado
-
GenSpera, Inc.RetiradoCancer de prostata.Estados Unidos
-
University of Colorado, DenverColorado State UniversityRetiradoRealidad virtual | Diagnóstico por imagen | Educación del paciente | Paciente con cancerEstados Unidos
-
Dana-Farber Cancer InstituteTerminadoCancer de RIÑON | Cancer de prostata | Cáncer genitourinarioEstados Unidos
-
Rabin Medical CenterReclutamiento
Ensayos clínicos sobre Biopsy
-
Aquyre Bioscience, IncBoston University; Fox Chase Cancer Center; Johnson & JohnsonReclutamiento
-
University Hospital, Basel, SwitzerlandTerminadoBiopsia de Médula ÓseaSuiza
-
Cliniques universitaires Saint-Luc- Université...Université de LiègeReclutamientoFibrosis quística | BiomarcadoresBélgica
-
Samsung Medical CenterDesconocido