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NCT05398822 Clinical Trial

The Role of TextRAd on Detection of Liver Metastasis in Rectal Cancer

Rectal Cancer Clinical Trial

Official title:
The Role of TextRAd on Detection of Liver Metastasis in Rectal Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05398822
Other study ID # 19/109
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 18, 2019
Est. completion date July 18, 2021

Study information
Verified date May 2022
Source East Suffolk and North Essex NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a retrospective analysis of all patients diagnosed with LARC who received NCRT and had MRI scans between 2003-2014 at East Suffolk and North Essex NHS Foundation Trust. Region of interest was drawn around the tumor or its location on T2 MRI images. Six texture parameters were systematically extracted from Textural histograms of post-treatment scans. These parameters were examined to determine their ability to predict local recurrence and distant metastases through Kaplan-Meier survival curves and log-rank tests.

Recruitment information / eligibility
Status Completed
Enrollment 113
Est. completion date July 18, 2021
Est. primary completion date July 18, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - All subjects must have MRI post-Chemotherapy treatment to detect the response to Neoadjuvant treatment and compare it to pre-treatment scans to easily determine if there were a posttreatment liver metastasis. - Locally advanced rectal cancer (LARC) = MRI stage: T3/T4 and/or N1/N0. Exclusion Criteria: - Distant metastases. - Synchronous tumour.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• MRI
Texture analysis (TA) is a novel imaging biomarker that can assess heterogeneity in MRIs by measuring grey-level intensities distribution. This study hypothesizes that TA of MRI is an imaging biomarker that can predict local recurrence and distant metastasis.

Locations
Country Name City State
United Kingdom East Suffolk and North Essex NHS Foundation Trust Ipswich

Sponsors (1)
Lead Sponsor Collaborator
East Suffolk and North Essex NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Local recurrence of rectal cancer 120 months
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