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NCT Number: 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.

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Key information

Conditions

Rectal Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Elasticity Imaging Techniques Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vejle Hospital

Vejle, Region Syddanmark, 7100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Shear Wave Elastography

Diagnostic Test

SWE value of rectal lesions

Primary outcomes

  1. SWE accuracy

    Time frame: 1 month

    The accuracy of SWE value as compared with the histopathology report

Secondary outcomes

  1. SWE and ADC measurement

    Time frame: 1 week

    The correlation between ERUS SWE and MRI ADC value

Sponsors and collaborators

Lead sponsor

Vejle Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 1, 2020
Registry last updated
Oct 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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