Shear Wave Elastography of Rectal Adenomas and Cancer

Not Applicable

Completed

• Conditions: Rectal Neoplasms; Elasticity Imaging Techniques
• Interventions: Diagnostic Test: Shear Wave Elastography

• Registration Number: NCT04409990
• Lead Sponsor: Vejle Hospital

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.

Study Timeline

• Study Start: 2020-03-02
• Study First Submitted: 2020-05-27
• Study First Submitted QC: 2020-05-27
• Study First Posted: 2020-06-01
• Primary Completion: 2022-08-31
• Status Verified: 2022-10
• Study Completion: 2022-10-01
• Last Update Submitted: 2022-10-04
• Last Update Posted: 2022-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Shear Wave Elastography	Shear Wave Elastography	SWE value measurement will be added during the ERUS examination.

Primary Outcome Measures

Name	Time	Method
SWE accuracy	1 month	The accuracy of SWE value as compared with the histopathology report

Secondary Outcome Measures

Name	Time	Method
SWE and ADC measurement	1 week	The correlation between ERUS SWE and MRI ADC value

Trial Locations

Locations (1)

Vejle Hospital; 🇩🇰 Vejle, Region Of Southern Denmark, Denmark