Esophageal CancerNCT05611658
Inter-observer Variation in Gross Tumor Delineation of Esophageal Cancer on MR, CT and PET CT
An observational study of Esophageal Cancer, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- MR, PET CT
- How many people
- 23 participants
- Where
- 1 siteSlovenia
- Study dates
- 20 May 2020to 30 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated for esophageal cancer with preoperative or curative chemoradiotherapy.
Who may be able to join
- locally advanced esophageal cancer eligible for treatment with preoperative or curative chemoradiotherapy
Who cannot join
- contraindications for MR
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Esophageal Cancer
- Being tested
- MR, PET CT
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR, PET CTOther
diagnostic method
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start20 May 2020
- Primary completion25 May 2021
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Oncology Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05611658
- Sponsor's protocol ID
- 525
- Status last verified
- Oct 2024
- First submitted
- 27 Oct 2022
- Last updated
- 17 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inter-observer Variation in Gross Tumor Delineation of Esophageal Cancer on MR, CT and PET CT
- ClinicalTrials.gov ID
- NCT05611658
- Acronym / sponsor ID
- 525
- Conditions
- Esophageal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Institute of Oncology LjubljanaUniversity, hospital or other
- Study start
- 20 May 2020 (actual)
- Primary completion
- 25 May 2021 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 10 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated for esophageal cancer with preoperative or curative chemoradiotherapy.
Key inclusion criteria (1 listed)
- locally advanced esophageal cancer eligible for treatment with preoperative or curative chemoradiotherapy
Key exclusion criteria (1 listed)
- contraindications for MR
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MR, PET CTdiagnostic method | Other | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
Related trials for Esophageal Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Cancer, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of interobserver variability in target volume delineation on CT, PET CT and MR. (time frame: Through study completion, an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2024.