Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
164 participants
INTERVENTIONAL
2020-03-02
2022-10-01
Brief Summary
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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.
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Detailed Description
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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:
1. Tumour stiffness measurement by SWE gives a statistically significantly higher value in malignant processes than in benign rectal tumors.
2. Tissue stiffness measurement with SWE gives a statistically significantly higher value in lymph node metastases than in reactive enlarged lymph nodes.
3. There is a statistically significant correlation between SWE and MRI apparent diffusion coefficient (ADC)
Histopathology report of surgical specimen will serve as endpoint.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Shear Wave Elastography
SWE value measurement will be added during the ERUS examination.
Shear Wave Elastography
SWE value of rectal lesions
Interventions
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Shear Wave Elastography
SWE value of rectal lesions
Eligibility Criteria
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Inclusion Criteria
* Rectal lesions discovered during endoscopy
* Lesions located no more than 15 cm above the anal verge
Exclusion Criteria
* Preoperative radiotherapy and/or chemotherapy
ALL
No
Sponsors
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Vejle Hospital
OTHER
Responsible Party
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Principal Investigators
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Søren R Rafaelsen, DMSc
Role: STUDY_CHAIR
Vejle Hospital
Locations
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Vejle Hospital
Vejle, Region Syddanmark, Denmark
Countries
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References
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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.
Other Identifiers
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SWE of rectal lesions
Identifier Type: -
Identifier Source: org_study_id
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