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OpenTrials
Completed

NCT Number: NCT05398822

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

East Suffolk and North Essex NHS Foundation Trust

Ipswich, IP4 5PD, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Local recurrence of rectal cancer

    Time frame: 120 months

Sponsors and collaborators

Lead sponsor

East Suffolk and North Essex NHS Foundation Trust

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 1, 2022
Registry last updated
Jun 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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