Shear Wave Elastography of Rectal Adenomas and Cancer

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 31, 2022

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.

Interventions

  • Diagnostic Test: Shear Wave Elastography
    • SWE value of rectal lesions

Arms, Groups and Cohorts

  • Other: Shear Wave Elastography
    • SWE value measurement will be added during the ERUS examination.

Clinical Trial Outcome Measures

Primary Measures

  • SWE accuracy
    • Time Frame: 1 month
    • The accuracy of SWE value as compared with the histopathology report

Secondary Measures

  • SWE and ADC measurement
    • Time Frame: 1 week
    • The correlation between ERUS SWE and MRI ADC value

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Vejle Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Søren R Rafaelsen, DMSc, Study Chair, Vejle Hospital

References

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.

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