Rectal Cancer
Conditions
Keywords
CEUS Perfusion, Rectal Cancer, Tumor Perfusion, Radiochemotherapy
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.
Interventions
PROCEDUREDynamic contrast enhanced ultrasound (D-CEUS) with Sonovue® administration
Dynamic contrast enhanced ultrasound (D-CEUS) with Sonovue® administration
Sponsors
University Hospital, Bordeaux
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the echo-power curve (AUC) | At inclusion, 3 months and 6 months visits |
Secondary
| Measure | 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 |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORArnaud HOCQUELET
University Hospital, Bordeaux
Outcome results
None listed