Rectal NeoplasmsNCT04409990
Shear Wave Elastography of Rectal Adenomas and Cancer
A study testing Shear Wave Elastography in people with Rectal Neoplasms and Elasticity Imaging Techniques, run by Vejle Hospital at 1 site in Denmark.
Trial summary
The diagnosis of rectal lesions is a challenging task, and the accuracy of the primary staging is important preoperatively. A relatively novel technology makes it possible to measure the tissue stiffness during endorectal ultrasonography. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rectal Neoplasms, Elasticity Imaging Techniques
- What is being tested?
- Shear Wave Elastography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteDenmark
- Study dates
- 2 Mar 2020to 1 Oct 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adults above 18 years of age
- Rectal lesions discovered during endoscopy
- Lesions located no more than 15 cm above the anal verge
Who cannot join
- Non-eligibility for MRI (e.g. claustrophobia, implants)
- Preoperative radiotherapy and/or chemotherapy
Trial locations and contacts
1 site in 1 country.
About this study
The diagnosis of rectal lesions is a challenging task, and the accuracy of the primary staging is important preoperatively. A relatively novel technology makes it possible to measure the tissue stiffness during endorectal ultrasonography.
The purpose of this study is to evaluate the diagnostic value of Shear Wave Elastography (SWE). The hypothesis is that the tissue stiffness is higher in malignant tissue than in benign lesions.
Read the detailed description
This study will include patients with an endoscopy verified rectal lesion referred to the radiology department for pretreatment evaluation.
During the investigation, patients will undergo magnetic resonance imaging (MRI) and endorectal ultrasonography (ERUS). During the ERUS, the tissue stiffness of the lesion and visible lymph nodes will be measured using the SWE technology.
Hypotheses:
- Tumour stiffness measurement by SWE gives a statistically significantly higher value in malignant processes than in benign rectal tumors.
- Tissue stiffness measurement with SWE gives a statistically significantly higher value in lymph node metastases than in reactive enlarged lymph nodes.
- There is a statistically significant correlation between SWE and MRI apparent diffusion coefficient (ADC)
Histopathology report of surgical specimen will serve as endpoint.
- Conditions
- Rectal Neoplasms, Elasticity Imaging Techniques
- Being tested
- Shear Wave Elastography
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shear Wave ElastographyDiagnostic test
SWE value of rectal lesions
| Study group | Role | What they receive |
|---|---|---|
| Shear Wave Elastography | Other | SWE value measurement will be added during the ERUS examination. Receives: Diagnostic Test: Shear Wave Elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
SWE accuracy
The accuracy of SWE value as compared with the histopathology report
Measured: 1 month
Secondary outcomes (1)
SWE and ADC measurement
The correlation between ERUS SWE and MRI ADC value
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start2 Mar 2020
- Primary completion31 Aug 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rectal NeoplasmsStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vejle Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Søren R Rafaelsen, DMSc, Study chair, Vejle Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04409990
- Sponsor's protocol ID
- SWE of rectal lesions
- Status last verified
- Oct 2022
- First submitted
- 27 May 2020
- Last updated
- 5 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li T, Lu M, Li Y, Li J, Hu Z, Li X, Cheng X, Jiang J, Tan B. Quantitative Elastography of Rectal Lesions: The Value ofShear Wave Elastography in Identifying Benign and Malignant Rectal Lesions. Ultrasound Med Biol. 2019 Jan;45(1):85-92. doi: 10.1016/j.ultrasmedbio.2018.09.008. Epub 2018 Oct 17.
PubMed 30342780
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shear Wave Elastography of Rectal Adenomas and Cancer
- ClinicalTrials.gov ID
- NCT04409990
- Acronym / sponsor ID
- SWE of rectal lesions
- Conditions
- Rectal Neoplasms, Elasticity Imaging Techniques
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Vejle HospitalUniversity, hospital or other
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 1 Jun 2020 (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.
The diagnosis of rectal lesions is a challenging task, and the accuracy of the primary staging is important preoperatively. A relatively novel technology makes it possible to measure the tissue stiffness during endorectal ultrasonography.
The purpose of this study is to evaluate the diagnostic value of Shear Wave Elastography (SWE). The hypothesis is that the tissue stiffness is higher in malignant tissue than in benign lesions.
Detailed description
This study will include patients with an endoscopy verified rectal lesion referred to the radiology department for pretreatment evaluation.
During the investigation, patients will undergo magnetic resonance imaging (MRI) and endorectal ultrasonography (ERUS). During the ERUS, the tissue stiffness of the lesion and visible lymph nodes will be measured using the SWE technology.
Hypotheses:
- Tumour stiffness measurement by SWE gives a statistically significantly higher value in malignant processes than in benign rectal tumors.
- Tissue stiffness measurement with SWE gives a statistically significantly higher value in lymph node metastases than in reactive enlarged lymph nodes.
- There is a statistically significant correlation between SWE and MRI apparent diffusion coefficient (ADC)
Histopathology report of surgical specimen will serve as endpoint.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shear Wave Elastography | Other | Diagnostic Test: Shear Wave ElastographySWE value measurement will be added during the ERUS examination. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Adults above 18 years of age
- Rectal lesions discovered during endoscopy
- Lesions located no more than 15 cm above the anal verge
Key exclusion criteria (2 listed)
- Non-eligibility for MRI (e.g. claustrophobia, implants)
- Preoperative radiotherapy and/or chemotherapy
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 |
|---|---|---|
| Shear Wave ElastographySWE value of rectal lesions | Diagnostic test | Shear Wave Elastography |
Primary outcome
SWE accuracy
Time frame: 1 month
The accuracy of SWE value as compared with the histopathology report
1 secondary outcome
SWE and ADC measurement
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2022.
- Background: PubMed 30342780Li T, Lu M, Li Y, Li J, Hu Z, Li X, Cheng X, Jiang J, Tan B. Quantitative Elastography of Rectal Lesions: The Value ofShear Wave Elastography in Identifying Benign and Malignant Rectal Lesions. Ultrasound Med Biol. 2019 Jan;45(1):85-92. doi: 10.1016/j.ultrasmedbio.2018.09.008. Epub 2018 Oct 17.
- 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.
Søren R Rafaelsen, DMSc study chair
Vejle Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shear Wave Elastography in people with Rectal Neoplasms and Elasticity Imaging Techniques, run by Vejle Hospital at 1 site in Denmark.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 5 Oct 2022. 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 Denmark. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
SWE accuracy (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04409990, which also lists 1 linked publication.
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 5 Oct 2022.