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

October 29, 2020 updated by: University Hospital, Bordeaux
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France
        • CHU de Bordeaux

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Chemotherapy and Radiochemotherapy
Procedure: Dynamic contrast enhanced ultrasound (D-CEUS) with Sonovue® administration
Dynamic contrast enhanced ultrasound (D-CEUS) with Sonovue® administration
Other: Radiochemotherapy
Procedure: Dynamic contrast enhanced ultrasound (D-CEUS) with Sonovue® administration
Dynamic contrast enhanced ultrasound (D-CEUS) with Sonovue® administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the echo-power curve (AUC)
Time Frame: At inclusion, 3 months and 6 months visits
At inclusion, 3 months and 6 months visits

Secondary Outcome Measures

Outcome Measure
Time Frame
Peak enhancement (PE)
Time Frame: At inclusion, 3 months and 6 months visits
At inclusion, 3 months and 6 months visits
Rise time (RT)
Time Frame: At inclusion, 3 months and 6 months visits
At inclusion, 3 months and 6 months visits
Wash-in area under the curve (WiAUC)
Time Frame: At inclusion, 3 months and 6 months visits
At inclusion, 3 months and 6 months visits
Mean transit time (mTT)
Time Frame: At inclusion, 3 months and 6 months visits
At inclusion, 3 months and 6 months visits
Time to peak (TTP)
Time Frame: At inclusion, 3 months and 6 months visits
At inclusion, 3 months and 6 months visits
Whash-in rate (WiR)
Time Frame: At inclusion, 3 months and 6 months visits
At inclusion, 3 months and 6 months visits
Wash out rate (WoR)
Time Frame: At inclusion, 3 months and 6 months visits
At inclusion, 3 months and 6 months visits
MRI assessed Tumor Response Grade (mrTRG)
Time Frame: At inclusion, 3 months and 6 months visits
At inclusion, 3 months and 6 months visits
mrTNM staging
Time Frame: At inclusion, 3 months and 6 months visits
At inclusion, 3 months and 6 months visits

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Investigators

  • Principal Investigator: Arnaud HOCQUELET, University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 18, 2018

Primary Completion (Actual)

November 8, 2018

Study Completion (Actual)

January 8, 2019

Study Registration Dates

First Submitted

January 5, 2017

First Submitted That Met QC Criteria

February 24, 2017

First Posted (Actual)

March 1, 2017

Study Record Updates

Last Update Posted (Actual)

October 30, 2020

Last Update Submitted That Met QC Criteria

October 29, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2015/17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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