Inter-observer Variation in Gross Tumor Delineation of Esophageal Cancer on MR, CT and PET CT

October 16, 2024 updated by: Institute of Oncology Ljubljana
The aim of the study is to investigate inter-observer variation in gross tumor volume (GTV) delineation of oesophageal cancer on different imaging modalities - CT, PET CT and MR.Twenty-three consecutive patients with esophageal cancer treated with preoperative or curative chemoradiotherapy were selected. All patients had CT, PET CT and MR imaging in treatment position prior to radiotherapy.Five experienced observers from our institution will independently delineate GTV on CT alone, MR alone, PET CT alone, on co-registered CT and MR and co-registered PET CT and MR. Inter-observer agreement, expressed in generalized conformity index (CIgen) and mean volumes of GTV will be calculated per patient and imaging modality.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

23

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Institute of Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients treated for esophageal cancer with preoperative or curative chemoradiotherapy.

Description

Inclusion Criteria:

  • locally advanced esophageal cancer eligible for treatment with preoperative or curative chemoradiotherapy

Exclusion Criteria:

  • contraindications for MR

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of interobserver variability in target volume delineation on CT, PET CT and MR.
Time Frame: Through study completion, an average of 1 year.
To compare target volume delineation of esophageal cancer using CT, PET CT and MR with determining generalized conformity indexes and mean volumes of GTV.
Through study completion, an average of 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Oncology Ljubljana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2020

Primary Completion (Actual)

May 25, 2021

Study Completion (Actual)

September 30, 2023

Study Registration Dates

First Submitted

October 27, 2022

First Submitted That Met QC Criteria

November 3, 2022

First Posted (Actual)

November 10, 2022

Study Record Updates

Last Update Posted (Actual)

October 17, 2024

Last Update Submitted That Met QC Criteria

October 16, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 525

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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