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Spots Global Cancer Trial Database for Shear Wave Elastography of Rectal Adenomas and Cancer

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Trial Identification

Brief Title: Shear Wave Elastography of Rectal Adenomas and Cancer

Official Title: Shear Wave Elastography of Rectal Adenomas and Cancer

Study ID: NCT04409990

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: 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.

Keywords

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Vejle Hospital, Vejle, Region Of Southern Denmark, Denmark

Contact Details

Name: Søren R Rafaelsen, DMSc

Affiliation: Vejle Hospital

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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