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Completed

NCT Number: NCT03068403

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Bordeaux

Bordeaux, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

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

Primary outcomes

  1. Area under the echo-power curve (AUC)

    Time frame: At inclusion, 3 months and 6 months visits

Secondary outcomes

  1. Peak enhancement (PE)

    Time frame: At inclusion, 3 months and 6 months visits

  2. Rise time (RT)

    Time frame: At inclusion, 3 months and 6 months visits

  3. Wash-in area under the curve (WiAUC)

    Time frame: At inclusion, 3 months and 6 months visits

  4. Mean transit time (mTT)

    Time frame: At inclusion, 3 months and 6 months visits

  5. Time to peak (TTP)

    Time frame: At inclusion, 3 months and 6 months visits

  6. Whash-in rate (WiR)

    Time frame: At inclusion, 3 months and 6 months visits

  7. Wash out rate (WoR)

    Time frame: At inclusion, 3 months and 6 months visits

  8. MRI assessed Tumor Response Grade (mrTRG)

    Time frame: At inclusion, 3 months and 6 months visits

  9. mrTNM staging

    Time frame: At inclusion, 3 months and 6 months visits

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: RECT

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Mar 1, 2017
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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