Shear Wave Elastography of Rectal Adenomas and Cancer
Primary Purpose
Rectal Neoplasms, Elasticity Imaging Techniques
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Shear Wave Elastography
Sponsored by
About this trial
This is an interventional diagnostic trial for Rectal Neoplasms
Eligibility Criteria
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
Sites / Locations
- Vejle Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Shear Wave Elastography
Arm Description
SWE value measurement will be added during the ERUS examination.
Outcomes
Primary Outcome Measures
SWE accuracy
The accuracy of SWE value as compared with the histopathology report
Secondary Outcome Measures
SWE and ADC measurement
The correlation between ERUS SWE and MRI ADC value
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04409990
Brief Title
Shear Wave Elastography of Rectal Adenomas and Cancer
Official Title
Shear Wave Elastography of Rectal Adenomas and Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
March 2, 2020 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
October 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vejle Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Neoplasms, Elasticity Imaging Techniques
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
164 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Shear Wave Elastography
Arm Type
Other
Arm Description
SWE value measurement will be added during the ERUS examination.
Intervention Type
Diagnostic Test
Intervention Name(s)
Shear Wave Elastography
Intervention Description
SWE value of rectal lesions
Primary Outcome Measure Information:
Title
SWE accuracy
Description
The accuracy of SWE value as compared with the histopathology report
Time Frame
1 month
Secondary Outcome Measure Information:
Title
SWE and ADC measurement
Description
The correlation between ERUS SWE and MRI ADC value
Time Frame
1 week
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Søren R Rafaelsen, DMSc
Organizational Affiliation
Vejle Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Vejle Hospital
City
Vejle
State/Province
Region Of Southern Denmark
ZIP/Postal Code
7100
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30342780
Citation
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.
Results Reference
background
Learn more about this trial
Shear Wave Elastography of Rectal Adenomas and Cancer
We'll reach out to this number within 24 hrs