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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05611658
Other study ID # 525
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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.
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