Rectal CancerRECTNCT03068403
Dynamic Contrast Enhanced Ultrasound for Predict and Assess Rectal Cancer Response After Neo-adjuvant Chemoradiation - RECT
A study testing Dynamic contrast enhanced ultrasound (D-CEUS) with Sonovue® administration in people with Rectal Cancer, run by University Hospital, Bordeaux at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Dynamic contrast enhanced ultrasound (D-CEUS) with Sonovue® administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jun 2018to 8 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Indication for immediate surgery
- Primary tumor not measured at the MRI before inclusion
- Previous pelvic radiotherapy
- Contraindication to SONOVUE or MRI
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Dynamic contrast enhanced ultrasound (D-CEUS) with Sonovue® administration
- Keywords
- CEUS Perfusion, Rectal Cancer, Tumor Perfusion, Radiochemotherapy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic contrast enhanced ultrasound (D-CEUS) with Sonovue® administrationProcedure or surgery
Dynamic contrast enhanced ultrasound (D-CEUS) with Sonovue® administration
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy and Radiochemotherapy | Other | Not described Receives: Procedure: Dynamic contrast enhanced ultrasound (D-CEUS) with Sonovue® administration |
| Radiochemotherapy | Other | Not described Receives: Procedure: Dynamic contrast enhanced ultrasound (D-CEUS) with Sonovue® administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the echo-power curve (AUC)
Measured: At inclusion, 3 months and 6 months visits
Secondary outcomes (9)
Peak enhancement (PE)
Measured: At inclusion, 3 months and 6 months visits
Rise time (RT)
Measured: At inclusion, 3 months and 6 months visits
Wash-in area under the curve (WiAUC)
Measured: At inclusion, 3 months and 6 months visits
Mean transit time (mTT)
Measured: At inclusion, 3 months and 6 months visits
Time to peak (TTP)
Measured: At inclusion, 3 months and 6 months visits
Whash-in rate (WiR)
Measured: At inclusion, 3 months and 6 months visits
Wash out rate (WoR)
Measured: At inclusion, 3 months and 6 months visits
MRI assessed Tumor Response Grade (mrTRG)
Measured: At inclusion, 3 months and 6 months visits
mrTNM staging
Measured: At inclusion, 3 months and 6 months visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2017
- Study start18 Jun 2018
- Primary completion8 Nov 2018
- Study completion8 Jan 2019
Why it stopped: target number of inclusion not reached
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnaud HOCQUELET, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03068403
- Sponsor's protocol ID
- CHUBX 2015/17
- Other IDs
- 2016-002589-30, 2016
- Acronym
- RECT
- Status last verified
- Oct 2020
- First submitted
- 5 Jan 2017
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Contrast Enhanced Ultrasound for Predict and Assess Rectal Cancer Response After Neo-adjuvant Chemoradiation - RECT
- ClinicalTrials.gov ID
- NCT03068403
- Acronym / sponsor ID
- RECT / CHUBX 2015/17
- Conditions
- Rectal Cancer
- Keywords
- CEUS Perfusion, Rectal Cancer, Tumor Perfusion, Radiochemotherapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: target number of inclusion not reached
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 18 Jun 2018 (actual)
- Primary completion
- 8 Nov 2018 (actual)
- Study completion
- 8 Jan 2019 (actual)
- First posted
- 1 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically confirmed rectal carcinoma
- Stade ≥T2 and tumor size ≥3cm
- No detectable metastases
- Patient ≥ 18 years
- Patient information and written informed consent form signed
Key exclusion criteria (4 listed)
- Indication for immediate surgery
- Primary tumor not measured at the MRI before inclusion
- Previous pelvic radiotherapy
- Contraindication to SONOVUE or MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dynamic contrast enhanced ultrasound (D-CEUS) with Sonovue® administrationDynamic contrast enhanced ultrasound (D-CEUS) with Sonovue® administration | Procedure or surgery | Chemotherapy and Radiochemotherapy, Radiochemotherapy |
Primary outcome
Area under the echo-power curve (AUC)
Time frame: At inclusion, 3 months and 6 months visits
9 secondary outcomes
Peak enhancement (PE)
Time frame: At inclusion, 3 months and 6 months visits
Rise time (RT)
Time frame: 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
Mean transit time (mTT)
Time frame: At inclusion, 3 months and 6 months visits
Time to peak (TTP)
Time frame: At inclusion, 3 months and 6 months visits
Whash-in rate (WiR)
Time frame: At inclusion, 3 months and 6 months visits
Wash out rate (WoR)
Time frame: At inclusion, 3 months and 6 months visits
MRI assessed Tumor Response Grade (mrTRG)
Time frame: At inclusion, 3 months and 6 months visits
mrTNM staging
Time frame: At inclusion, 3 months and 6 months visits
Results and safety
The study was stopped early (reason given: target number of inclusion not reached). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnaud HOCQUELET principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic contrast enhanced ultrasound (D-CEUS) with Sonovue® administration in people with Rectal Cancer, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: target number of inclusion not reached). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the echo-power curve (AUC) (time frame: At inclusion, 3 months and 6 months visits). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.