Shear Wave Elastography of Rectal Adenomas and Cancer

Rectal Neoplasms Clinical Trial

Official title:

Shear Wave Elastography of Rectal Adenomas and Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04409990
• Other study ID #: SWE of rectal lesions
• Status: Completed
• Phase: N/A
• Start date: March 2, 2020
• Est. completion date: October 1, 2022

Study information

• Verified date: October 2022
• Source: Vejle Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: October 1, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Elasticity Imaging Techniques
• Rectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
Denmark	Vejle Hospital	Vejle	Region Of Southern Denmark

Sponsors (1)

Lead Sponsor	Collaborator
Vejle Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SWE accuracy	The accuracy of SWE value as compared with the histopathology report	1 month
Secondary	SWE and ADC measurement	The correlation between ERUS SWE and MRI ADC value	1 week