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

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05611658
• Other study ID #: 525
• Status: Active, not recruiting
• Start date: May 20, 2020
• Est. completion date: September 2023

Study information

• Verified date: November 2022
• Source: Institute of Oncology Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 23
• Est. completion date: September 2023
• Est. primary completion date: May 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• contraindications for MR

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Other:
• MR, PET CT
diagnostic method

Locations

Country	Name	City	State
Slovenia	Institute of Oncology	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Oncology Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of interobserver variability in target volume delineation on CT, PET CT and MR.	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.