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

NCT03068403 | Completed

• 2 other identifiers: CHUBX 2015/172016-002589-30
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer

Keywords

CEUS Perfusion; Rectal Cancer; Tumor Perfusion; Radiochemotherapy

Outcome Measures

Primary Outcomes (1)

• Area under the echo-power curve (AUC)

  At inclusion, 3 months and 6 months visits

Secondary Outcomes (9)

• Peak enhancement (PE)

  At inclusion, 3 months and 6 months visits

• Rise time (RT)

  At inclusion, 3 months and 6 months visits

• Wash-in area under the curve (WiAUC)

  At inclusion, 3 months and 6 months visits

• Mean transit time (mTT)

  At inclusion, 3 months and 6 months visits

• Time to peak (TTP)

  At inclusion, 3 months and 6 months visits

Study Arms (2)

Chemotherapy and Radiochemotherapy

OTHER

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

Radiochemotherapy

OTHER

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

Interventions

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

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

Chemotherapy and Radiochemotherapy; Radiochemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Indication for immediate surgery
• Previous pelvic radiotherapy
• Contraindication to SONOVUE or MRI

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU de Bordeaux

Bordeaux, France

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Arnaud HOCQUELET

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2017
• First Posted: March 1, 2017
• Study Start: June 18, 2018
• Primary Completion: November 8, 2018
• Study Completion: January 8, 2019
• Last Updated: May 22, 2026

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)