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

Rectal Cancer Clinical Trial

— RECT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03068403
• Other study ID #: CHUBX 2015/17
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

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