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

• Sponsor: University Hospital, Bordeaux (Other)
• Overall Status: Completed
• CT.gov ID: NCT03068403
• Collaborator: (none)
• Enrollment: 2
• Location: 1
• Arms: 2
• Actual Duration (Months): 6.7
• Patients Per Site Per Month: 0.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Rectal Cancer	Procedure: Dynamic contrast enhanced ultrasound (D-CEUS) with Sonovue® administration	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Dynamic Contrast Enhanced Ultrasound for Predict and Assess Rectal Cancer Response After Neo-adjuvant Chemoradiation - RECT
• Actual Study Start Date: Jun 18, 2018
• Actual Primary Completion Date: Nov 8, 2018
• Actual Study Completion Date: Jan 8, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Area under the echo-power curve (AUC) [At inclusion, 3 months and 6 months visits]

Secondary Outcome Measures

1. Peak enhancement (PE) [At inclusion, 3 months and 6 months visits]

2. Rise time (RT) [At inclusion, 3 months and 6 months visits]

3. Wash-in area under the curve (WiAUC) [At inclusion, 3 months and 6 months visits]

4. Mean transit time (mTT) [At inclusion, 3 months and 6 months visits]

5. Time to peak (TTP) [At inclusion, 3 months and 6 months visits]

6. Whash-in rate (WiR) [At inclusion, 3 months and 6 months visits]

7. Wash out rate (WoR) [At inclusion, 3 months and 6 months visits]

8. MRI assessed Tumor Response Grade (mrTRG) [At inclusion, 3 months and 6 months visits]

9. mrTNM staging [At inclusion, 3 months and 6 months visits]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Bordeaux	Bordeaux		France

Sponsors and Collaborators

• University Hospital, Bordeaux

Investigators

• Principal Investigator: Arnaud HOCQUELET, University Hospital, Bordeaux

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Bordeaux
• ClinicalTrials.gov Identifier: NCT03068403
• Other Study ID Numbers: CHUBX 2015/17
• First Posted: Mar 1, 2017
• Last Update Posted: Oct 30, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Bordeaux: CEUS Perfusion; Rectal Cancer; Tumor Perfusion; Radiochemotherapy
• Additional relevant MeSH terms: Rectal Neoplasms

Study Results

No Results Posted as of Oct 30, 2020