Shear Wave Elastography of Rectal Adenomas and Cancer

Vejle Hospital

Status: Completed

Conditions: Elasticity Imaging Techniques; Rectal Neoplasms

Treatments: Diagnostic Test: Shear Wave Elastography

Study type: Interventional

Funder types: Other

Identifiers

NCT04409990

SWE of rectal lesions

Details and patient eligibility

About

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.

Full 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.

Enrollment: 164 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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164 participants in 1 patient group

Shear Wave Elastography

Other group

Description:

SWE value measurement will be added during the ERUS examination.

Treatment:

Diagnostic Test: Shear Wave Elastography