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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-002589-30 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemotherapy and Radiochemotherapy | Other |
| |
| Radiochemotherapy | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dynamic contrast enhanced ultrasound (D-CEUS) with Sonovue® administration | Procedure | Dynamic contrast enhanced ultrasound (D-CEUS) with Sonovue® administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the echo-power curve (AUC) | At inclusion, 3 months and 6 months visits |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arnaud HOCQUELET | University Hospital, Bordeaux | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Bordeaux | Bordeaux | France |
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| 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 |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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