Clinical trial NCT03068403: Dynamic Contrast Enhanced Ultrasound for Predict and Assess Rectal Cancer Response After Neo-adjuvant Chemoradiation - RECT
Official title: Dynamic Contrast Enhanced Ultrasound for Predict and Assess Rectal Cancer Response After Neo-adjuvant Chemoradiation - RECT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectal Cancer
Keywords: CEUS Perfusion
Rectal Cancer
Tumor Perfusion
Radiochemotherapy
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2017-03-01
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Area under the echo-power curve (AUC)
timeFrame: At inclusion, 3 months and 6 months visits
Secondary outcomes:
measure: Peak enhancement (PE)
timeFrame: At inclusion, 3 months and 6 months visits
measure: Rise time (RT)
timeFrame: At inclusion, 3 months and 6 months visits
measure: Wash-in area under the curve (WiAUC)
timeFrame: At inclusion, 3 months and 6 months visits
measure: Mean transit time (mTT)
timeFrame: At inclusion, 3 months and 6 months visits
measure: Time to peak (TTP)
timeFrame: At inclusion, 3 months and 6 months visits
measure: Whash-in rate (WiR)
timeFrame: At inclusion, 3 months and 6 months visits
measure: Wash out rate (WoR)
timeFrame: At inclusion, 3 months and 6 months visits
measure: MRI assessed Tumor Response Grade (mrTRG)
timeFrame: At inclusion, 3 months and 6 months visits
measure: mrTNM staging
timeFrame: At inclusion, 3 months and 6 months visits
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
Study officials:
affiliation: University Hospital, Bordeaux
name: Arnaud HOCQUELET
role: PRINCIPAL_INVESTIGATOR
References: