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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03068403
Other study ID # CHUBX 2015/17
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 18, 2018
Est. completion date January 8, 2019

Study information

Verified date October 2020
Source University Hospital, Bordeaux
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 2
Est. completion date January 8, 2019
Est. primary completion date November 8, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Dynamic contrast enhanced ultrasound (D-CEUS) with Sonovue® administration
Dynamic contrast enhanced ultrasound (D-CEUS) with Sonovue® administration

Locations

Country Name City State
France CHU de Bordeaux Bordeaux

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Area under the echo-power curve (AUC) At inclusion, 3 months and 6 months visits
Secondary Peak enhancement (PE) At inclusion, 3 months and 6 months visits
Secondary Rise time (RT) At inclusion, 3 months and 6 months visits
Secondary Wash-in area under the curve (WiAUC) At inclusion, 3 months and 6 months visits
Secondary Mean transit time (mTT) At inclusion, 3 months and 6 months visits
Secondary Time to peak (TTP) At inclusion, 3 months and 6 months visits
Secondary Whash-in rate (WiR) At inclusion, 3 months and 6 months visits
Secondary Wash out rate (WoR) At inclusion, 3 months and 6 months visits
Secondary MRI assessed Tumor Response Grade (mrTRG) At inclusion, 3 months and 6 months visits
Secondary mrTNM staging At inclusion, 3 months and 6 months visits
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