- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04409990
Shear Wave Elastography of Rectal Adenomas and Cancer
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Region Of Southern Denmark
-
Vejle, Region Of Southern Denmark, Denmark, 7100
- Vejle Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adults above 18 years of age
- Rectal lesions discovered during endoscopy
- Lesions located no more than 15 cm above the anal verge
Exclusion Criteria:
- Non-eligibility for MRI (e.g. claustrophobia, implants)
- Preoperative radiotherapy and/or chemotherapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Shear Wave Elastography
SWE value measurement will be added during the ERUS examination.
|
SWE value of rectal lesions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SWE accuracy
Time Frame: 1 month
|
The accuracy of SWE value as compared with the histopathology report
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SWE and ADC measurement
Time Frame: 1 week
|
The correlation between ERUS SWE and MRI ADC value
|
1 week
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Søren R Rafaelsen, DMSc, Vejle Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Adenoma
- Rectal Neoplasms
Other Study ID Numbers
- SWE of rectal lesions
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Rectal Neoplasms
-
Ohio State University Comprehensive Cancer CenterNovartis Pharmaceuticals; National Comprehensive Cancer NetworkCompletedStage IIA Rectal Cancer | Stage IIB Rectal Cancer | Stage IIC Rectal Cancer | Stage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Recurrent Rectal CancerUnited States
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI)WithdrawnStage IIA Rectal Cancer | Stage IIB Rectal Cancer | Stage IIC Rectal Cancer | Stage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Rectal AdenocarcinomaUnited States
-
SafeHeal IncTerminatedSafeHeal Colovac Colorectal Anastomosis Protection Device Evaluation (SAFE-2) Pivotal Study (SAFE-2)Colorectal Cancer | Rectal Cancer | Rectal Tumor | Rectal/AnalUnited States, France, Belgium
-
National Cancer Institute (NCI)NRG OncologyCompletedRectal Adenocarcinoma | Stage III Rectal Cancer AJCC v7 | Stage II Rectal Cancer AJCC v7United States, Puerto Rico
-
National Cancer Institute (NCI)TerminatedStage III Rectal Cancer AJCC v8 | Rectal Adenocarcinoma | Stage II Rectal Cancer AJCC v8 | Locally Advanced Rectal CarcinomaUnited States
-
City of Hope Medical CenterWithdrawnRecurrent Rectal Cancer | Stage I Rectal Cancer | Stage II Rectal Cancer | Stage III Rectal Cancer
-
OHSU Knight Cancer InstituteOregon Health and Science University; Taiho Pharmaceutical Co., Ltd.RecruitingStage III Rectal Cancer AJCC v8 | Stage IIIA Rectal Cancer AJCC v8 | Stage IIIB Rectal Cancer AJCC v8 | Stage IIIC Rectal Cancer AJCC v8 | Rectal Adenocarcinoma | Stage IIA Rectal Cancer AJCC v8 | Stage IIB Rectal Cancer AJCC v8United States
-
Peking University Third HospitalRecruitingRectal Cancer Stage II | Rectal Cancer Stage IIIChina
-
Prof. Dr. med. Claus RödelJohann Wolfgang Goethe University Hospital; Deutsche Krebshilfe e.V., Bonn...CompletedRectal Neoplasms | Rectal Cancer Stage II | Rectal Cancer Stage IIIGermany
-
GlaxoSmithKlineRecruitingNeoplasms, RectalUnited States, France, Italy, Japan, Spain, United Kingdom, Germany, Korea, Republic of, Canada, Netherlands
Clinical Trials on Shear Wave Elastography
-
Istanbul UniversityCompletedAdenomyosis | Elastography | Transvaginal Ultrasound | Fibroid UterusTurkey
-
Mayo ClinicRecruitingRespiratory Complication | Respiratory Function LossUnited States
-
Ramzy Raafat Mohamed Mohamed Elnabarawy, MD, MSc...Cairo UniversityCompletedTo Investigate the Value of Penile Elastography in the Diagnosis of Fibrosis of CCEgypt
-
University of DundeeCompleted
-
Istanbul UniversityCompleted
-
Assistance Publique - Hôpitaux de ParisCompletedIntensive Care Unit | Ventilator WeaningFrance
-
Fábio FernandesPfizerUnknown
-
Assiut UniversityNot yet recruiting
-
Assiut UniversityNot yet recruitingPancreatic Diseases | Shear Wave Elastography