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Shear Wave Elastography of Rectal Adenomas and Cancer

Shear Wave Elastography of Rectal Adenomas and Cancer

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04409990
Enrollment
164
Registered
2020-06-01
Start date
2020-03-02
Completion date
2022-10-01
Last updated
2022-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elasticity Imaging Techniques, Rectal Neoplasms

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.

Interventions

DIAGNOSTIC_TESTShear Wave Elastography

SWE value of rectal lesions

Sponsors

Vejle Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
SWE accuracy1 monthThe accuracy of SWE value as compared with the histopathology report

Secondary

MeasureTime frameDescription
SWE and ADC measurement1 weekThe correlation between ERUS SWE and MRI ADC value

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026