NCT04409990

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
164

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 2, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 1, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

October 5, 2022

Status Verified

October 1, 2022

Enrollment Period

2.5 years

First QC Date

May 27, 2020

Last Update Submit

October 4, 2022

Conditions

Rectal NeoplasmsElasticity Imaging Techniques

Outcome Measures

Primary Outcomes (1)

  • SWE accuracy

    The accuracy of SWE value as compared with the histopathology report

    1 month

Secondary Outcomes (1)

  • SWE and ADC measurement

    1 week

Study Arms (1)

Shear Wave Elastography

OTHER

SWE value measurement will be added during the ERUS examination.

Diagnostic Test: Shear Wave Elastography

Interventions

Shear Wave ElastographyDIAGNOSTIC_TEST

SWE value of rectal lesions

Shear Wave Elastography

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Adults above 18 years of age
  • Rectal lesions discovered during endoscopy
  • Lesions located no more than 15 cm above the anal verge

You may not qualify if:

  • Non-eligibility for MRI (e.g. claustrophobia, implants)
  • Preoperative radiotherapy and/or chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vejle Hospital

Vejle, Region Syddanmark, 7100, Denmark

Location

Related 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.

    PMID: 30342780BACKGROUND

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Søren R Rafaelsen, DMSc

    Vejle Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2020

First Posted

June 1, 2020

Study Start

March 2, 2020

Primary Completion

August 31, 2022

Study Completion

October 1, 2022

Last Updated

October 5, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)