Dynamic Contrast Enhanced Ultrasound for Predict and Assess Rectal Cancer Response After Neo-adjuvant Chemoradiation - RECT
- Conditions
- Rectal Cancer
- Interventions
- Procedure: Dynamic contrast enhanced ultrasound (D-CEUS) with Sonovue® administration
- Registration Number
- NCT03068403
- Lead Sponsor
- University Hospital, Bordeaux
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2
- 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
- Indication for immediate surgery
- Primary tumor not measured at the MRI before inclusion
- Previous pelvic radiotherapy
- Contraindication to SONOVUE or MRI
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Chemotherapy and Radiochemotherapy Dynamic contrast enhanced ultrasound (D-CEUS) with Sonovue® administration - Radiochemotherapy Dynamic contrast enhanced ultrasound (D-CEUS) with Sonovue® administration -
- Primary Outcome Measures
Name Time Method Area under the echo-power curve (AUC) At inclusion, 3 months and 6 months visits
- Secondary Outcome Measures
Name Time Method Rise time (RT) At inclusion, 3 months and 6 months visits mrTNM staging At inclusion, 3 months and 6 months visits Peak enhancement (PE) 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
Trial Locations
- Locations (1)
CHU de Bordeaux
🇫🇷Bordeaux, France