Dynamic Contrast Enhanced Ultrasound for Predict and Assess Rectal Cancer Response After Neo-adjuvant Chemoradiation - RECT

Dynamic Contrast Enhanced Ultrasound for Predict and Assess Rectal Cancer Response After Neo-adjuvant Chemoradiation - RECT

Patrocinadores

Patrocinador principal: University Hospital, Bordeaux

Fuente University Hospital, Bordeaux
Resumen breve

In recent years the concept of organ sparing treatment in rectal cancer was introduced for selected good responders after neo-adjuvant treatment. In these patients replacement of the standard of care total mesorectal excision (TME) by transanal endoscopic microsurgery (TEM) or omission of surgery after chemoradiation (CRT) was proposed. Before organ sparing treatments could be applied in clinical practice a reliable patient selection procedure has to be available as only good treatment responders after neo-adjuvant therapy are candidates for such adapted therapy. Different imaging modalities have been studied for their ability to distinguish good treatment responders from others. Examples of such imaging modalities with some promising results regarding response assessment are fludeoxyglucosepositron emission tomography (FDG-PET), T2-weighted magnetic resonance imaging (T2w-MRI), dynamic contrast enhanced magnetic resonance imaging and diffusion weighted MR imaging (DW-MRI). Besides these modalities dynamic contrast enhanced ultrasound (D-CEUS) is a new modality used for tissue characterization and therapy response assessment in several tumor locations, like liver tumors and breast cancer. D-CEUS reflect tissue vascular perfusion. For rectal cancer, the value of D-CEUS for pathological response prediction and assessment has never been assessed. Therefore, in this study we assessed D-CEUS to predict and assess pathological response in rectal cancer after neo-adjuvant CRT.

Estado general Completed
Fecha de inicio June 18, 2018
Fecha de Terminación January 8, 2019
Fecha de finalización primaria November 8, 2018
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Area under the echo-power curve (AUC) At inclusion, 3 months and 6 months visits
Resultado secundario
Medida Periodo de tiempo
Peak enhancement (PE) At inclusion, 3 months and 6 months visits
Rise time (RT) At inclusion, 3 months and 6 months visits
Wash-in area under the curve (WiAUC) At inclusion, 3 months and 6 months visits
Mean transit time (mTT) At inclusion, 3 months and 6 months visits
Time to peak (TTP) At inclusion, 3 months and 6 months visits
Whash-in rate (WiR) At inclusion, 3 months and 6 months visits
Wash out rate (WoR) At inclusion, 3 months and 6 months visits
MRI assessed Tumor Response Grade (mrTRG) At inclusion, 3 months and 6 months visits
mrTNM staging At inclusion, 3 months and 6 months visits
Inscripción 2
Condición
Intervención

Tipo de intervención: Procedure

Nombre de intervención: Dynamic contrast enhanced ultrasound (D-CEUS) with Sonovue® administration

Descripción: Dynamic contrast enhanced ultrasound (D-CEUS) with Sonovue® administration

Elegibilidad

Criterios:

Inclusion Criteria: - Histologically confirmed rectal carcinoma - Stade ≥T2 and tumor size ≥3cm - No detectable metastases - Patient ≥ 18 years - Patient information and written informed consent form signed - Patient who can receive radiotherapy and chemotherapy - Negative pregnancy test in women of childbearing potential - Patient covered by a Social Security system Exclusion Criteria: - Indication for immediate surgery - Primary tumor not measured at the MRI before inclusion - Previous pelvic radiotherapy - Contraindication to SONOVUE or MRI

Género: All

Edad mínima: 18 Years

Edad máxima: N/A

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Arnaud HOCQUELET Principal Investigator University Hospital, Bordeaux
Ubicación
Instalaciones: CHU de Bordeaux
Ubicacion Paises

France

Fecha de verificación

October 2020

Fiesta responsable

Tipo: Sponsor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 2
Grupo de brazo

Etiqueta: Chemotherapy and Radiochemotherapy

Tipo: Other

Etiqueta: Radiochemotherapy

Tipo: Other

Acrónimo RECT
Datos del paciente No
Información de diseño del estudio

Asignación: Non-Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Other

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov