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

NCT05398822 | Completed

• 1 other identifier: 19/109
• Study Type: observational
• Target: 113
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• Local recurrence of rectal cancer

  120 months

Interventions

MRI DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with locally advanced rectal cancer (LARC) includes neoadjuvant chemoradiotherapy (NCRT) followed by surgical resection

You may qualify if:

• 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.

You may not qualify if:

• Distant metastases.
• Synchronous tumour.

Sponsors & Collaborators

• East Suffolk and North Essex NHS Foundation Trust: lead

Study Sites (1)

East Suffolk and North Essex NHS Foundation Trust

Ipswich, IP4 5PD, United Kingdom

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: June 1, 2022
• Study Start: July 18, 2019
• Primary Completion: July 18, 2021
• Study Completion: July 18, 2021
• Last Updated: June 1, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)