Dynamic Contrast Enhanced Ultrasound for Predict and Assess Rectal Cancer Response After Neo-adjuvant Chemoradiation - RECT (RECT)
Primary Purpose
Rectal Cancer
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Dynamic contrast enhanced ultrasound (D-CEUS) with Sonovue® administration
Sponsored by
About this trial
This is an interventional other trial for Rectal Cancer focused on measuring CEUS Perfusion, Rectal Cancer, Tumor Perfusion, Radiochemotherapy
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
Sites / Locations
- CHU de Bordeaux
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Chemotherapy and Radiochemotherapy
Radiochemotherapy
Arm Description
Outcomes
Primary Outcome Measures
Area under the echo-power curve (AUC)
Secondary Outcome Measures
Peak enhancement (PE)
Rise time (RT)
Wash-in area under the curve (WiAUC)
Mean transit time (mTT)
Time to peak (TTP)
Whash-in rate (WiR)
Wash out rate (WoR)
MRI assessed Tumor Response Grade (mrTRG)
mrTNM staging
Full Information
NCT ID
NCT03068403
First Posted
January 5, 2017
Last Updated
October 29, 2020
Sponsor
University Hospital, Bordeaux
1. Study Identification
Unique Protocol Identification Number
NCT03068403
Brief Title
Dynamic Contrast Enhanced Ultrasound for Predict and Assess Rectal Cancer Response After Neo-adjuvant Chemoradiation - RECT
Acronym
RECT
Official Title
Dynamic Contrast Enhanced Ultrasound for Predict and Assess Rectal Cancer Response After Neo-adjuvant Chemoradiation - RECT
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
June 18, 2018 (Actual)
Primary Completion Date
November 8, 2018 (Actual)
Study Completion Date
January 8, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
CEUS Perfusion, Rectal Cancer, Tumor Perfusion, Radiochemotherapy
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Chemotherapy and Radiochemotherapy
Arm Type
Other
Arm Title
Radiochemotherapy
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Dynamic contrast enhanced ultrasound (D-CEUS) with Sonovue® administration
Intervention Description
Dynamic contrast enhanced ultrasound (D-CEUS) with Sonovue® administration
Primary Outcome Measure Information:
Title
Area under the echo-power curve (AUC)
Time Frame
At inclusion, 3 months and 6 months visits
Secondary Outcome Measure Information:
Title
Peak enhancement (PE)
Time Frame
At inclusion, 3 months and 6 months visits
Title
Rise time (RT)
Time Frame
At inclusion, 3 months and 6 months visits
Title
Wash-in area under the curve (WiAUC)
Time Frame
At inclusion, 3 months and 6 months visits
Title
Mean transit time (mTT)
Time Frame
At inclusion, 3 months and 6 months visits
Title
Time to peak (TTP)
Time Frame
At inclusion, 3 months and 6 months visits
Title
Whash-in rate (WiR)
Time Frame
At inclusion, 3 months and 6 months visits
Title
Wash out rate (WoR)
Time Frame
At inclusion, 3 months and 6 months visits
Title
MRI assessed Tumor Response Grade (mrTRG)
Time Frame
At inclusion, 3 months and 6 months visits
Title
mrTNM staging
Time Frame
At inclusion, 3 months and 6 months visits
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnaud HOCQUELET
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Bordeaux
City
Bordeaux
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Dynamic Contrast Enhanced Ultrasound for Predict and Assess Rectal Cancer Response After Neo-adjuvant Chemoradiation - RECT
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