Esophageal NeoplasmsNCT02182804

A Diagnostic Study of the Advanced Endoscopy to Detect Early Esophageal Cancer

A study testing Olympus and Cellvizio in people with Esophageal Neoplasms, run by King Chulalongkorn Memorial Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This descriptive cross sectional study aims to directly compare the diagnostic capability of the probed-based confocal laser endomicroscopy (pCLE) and the magnifying narrow band imaging (M-NBI) in the Lugol's voiding lesions. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Esophageal Neoplasms
What is being tested?: Olympus and Cellvizio
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 44 participants
Where: No sites listed yet
Study dates: Feb 2013to Jun 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age over 20 years
Having histological-confirmed diagnosis of head and neck cancer
Having no esophageal symptoms

Who cannot join

Having index cancer of nasopharynx
History of esophageal surgery
Having esophageal stricture or obstruction
Having esophageal varices
Known case of esophageal cancer
Uncorrectable coagulopathy and thrombocytopenia

Show all 10Show fewer

Pregnancy
Thyrotoxicosis
Creatinine clearance less than 30 ml/min
Allergy to iodine or fluorescein.

About this study

Official title: Diagnostic Values of Probe-based Confocal Laser Endomicroscopy (pCLE) and Magnifying Narrow Band Imaging (M-NBI) for Early Neoplasms Detection in Esophageal Lugol'S-voiding Lesions.

Conditions: Esophageal Neoplasms
Being tested: Olympus, Cellvizio
Keywords: Confocal Laser Endomicroscopy, Narrow Band Imaging, Lugol Chromoendoscopy, Esophageal Neoplasm, Head and Neck Cancer
Medical subject headings: Esophageal Neoplasms, Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OlympusDevice
narrow band imaging with magnification
CellvizioDevice
probe-based confocal laser endomicroscopy

Study groups in NCT02182804
Study group	Role	What they receive
Study	Experimental	probe-based confocal laser endomicroscopy narrow band imaging with magnification Receives: Device: Olympus; Device: Cellvizio

What is being measured

The primary outcome is the main question the study is designed to answer.

Accuracy
Diagnostic performance of the pCLE and M-NBI in Lugol's voiding lesions size larger than 5 millimeters.
Measured: an expected average of 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2013Jun 2014

First posted8 Jul 2014 (estimated)
Study startFeb 2013
Primary completionJun 2014
Study completionJun 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Esophageal NeoplasmsStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02182804
Sponsor's protocol ID: RP008
Status last verified: Aug 2020
First submitted: 1 Jul 2014
Last updated: 28 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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

All Esophageal Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Diagnostic Values of Probe-based Confocal Laser Endomicroscopy (pCLE) and Magnifying Narrow Band Imaging (M-NBI) for Early Neoplasms Detection in Esophageal Lugol'S-voiding Lesions.
ClinicalTrials.gov ID: NCT02182804
Acronym / sponsor ID: RP008
Conditions: Esophageal Neoplasms
Keywords: Confocal Laser Endomicroscopy, Narrow Band Imaging, Lugol Chromoendoscopy, Esophageal Neoplasm, Head and Neck Cancer
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: King Chulalongkorn Memorial HospitalUniversity, hospital or other
Collaborators: Chulalongkorn University
Study start: Feb 2013
Primary completion: Jun 2014 (actual)
Study completion: Jun 2014 (actual)
First posted: 8 Jul 2014 (estimated)
Results: Posted 28 Aug 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Study	Experimental	Device: Olympus, Device: Cellvizioprobe-based confocal laser endomicroscopy narrow band imaging with magnification

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Age over 20 years
Having histological-confirmed diagnosis of head and neck cancer
Having no esophageal symptoms

Key exclusion criteria (10 listed)

Having index cancer of nasopharynx
History of esophageal surgery
Having esophageal stricture or obstruction
Having esophageal varices
Known case of esophageal cancer

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
Olympusnarrow band imaging with magnification	Device	Study
Cellvizioprobe-based confocal laser endomicroscopy	Device	Study

Primary outcome

Accuracy
Time frame: an expected average of 2 weeks
Diagnostic performance of the pCLE and M-NBI in Lugol's voiding lesions size larger than 5 millimeters.

Results and safety

Results posted to the registry on 28 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Study Arm	44	44

Primary outcome: Accuracy

Time frame: an expected average of 2 weeks. Number (95% Confidence Interval). Unit: Percentage of accuracy

Measure	Study Arm n = 12
pCLE	89 (67 to 97)
dNBI	70 (48 to 85)

Population analysed: Twenty-one Lugol's voiding lesions larger than 5mm were detected in 12 patients.

Adverse events

Time frame: Intraprocedural.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Study Arm	0 of 44 (0%)	1 of 44 (2.3%)	0 of 44

Limitations and caveats (from the sponsor): This was a pilot study and the sample size was small. We did not randomly assign the order of dNBI and pCLE. The unwashed Lugol's stain significantly influenced the observation of IPCL structure on dNBI study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Esophageal Neoplasms

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.

Rapat Pittayanon, M.D. principal investigator

King Chulalongkorn Memorial Hospital

Questions about this trial

What is this clinical trial studying?

A study testing Olympus and Cellvizio in people with Esophageal Neoplasms, run by King Chulalongkorn Memorial Hospital.

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 3 inclusion and 10 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 28 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 28 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Accuracy (time frame: an expected average of 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02182804.

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 28 Aug 2020.