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

Study Overview
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Brief Summary
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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.

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

Conditions
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Rectal Cancer

Intervention / Treatment
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* Procedure: Dynamic contrast enhanced ultrasound (D-CEUS) with Sonovue® administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Chemotherapy and Radiochemotherapy<br> | Procedure: Dynamic contrast enhanced ultrasound (D-CEUS) with Sonovue® administration<br>* Dynamic contrast enhanced ultrasound (D-CEUS) with Sonovue® administration<br>|
| Other: Radiochemotherapy<br> | Procedure: Dynamic contrast enhanced ultrasound (D-CEUS) with Sonovue® administration<br>* Dynamic contrast enhanced ultrasound (D-CEUS) with Sonovue® administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the echo-power curve (AUC) |  | At inclusion, 3 months and 6 months visits | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CEUS Perfusion, Rectal Cancer, Tumor Perfusion, Radiochemotherapy