Blue Laser Imaging (BLI) for Detection of Secondary Head and Neck Cancer

July 12, 2023 updated by: Georg Dultz

Detection Rate by Blue Laser Imaging (BLI) of Secondary or Early Squamous Head and Neck Cancer in Patients Undergoing Elective Percutaneous Endoscopic Gastrostomy (PEG)

This study wants to focus on Carcinoma detection rates with blue laser imaging (BLI) for participants with head-neck cancer who need a percutaneous endoscopic gastrostomy (PEG). BLI is a new imaging technique that can easily be used within a standard gastroscopy.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Head-Neck cancers are a significant burden all around the world. Patients suffering from one tumor are at high risk for a second cancer or another precancerous lesion. Before or during cancer treatment a PEG is needed to maintain a sufficient calories intake. PEG is established by performing a standard gastroscopy.

This randomised study wants to compare the detection rates of standard white light endoscopy compared to the additional use of blue laser imaging for second cancers or precancerous lesions in participants presenting for PEG establishment.

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Germany
    • Hessen
      • Frankfurt am Main, Hessen, Germany, 60590
        • Klinikum der J. W. Goethe-Universität

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

Description

Inclusion Criteria:

  • All participants with the need of PEG due to head neck cancers or esophageal carcinoma

Exclusion Criteria:

  • Minors, pregnant women, contraindication for endoscopy, contraindications for establishment of a PEG

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

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard White Light Imaging
In this group the participants will be examined by white light endoscopy first and secondly with blue laser imaging technique during the same gastroscopy.
Diagnostic test: blue laser imaging
The intervention is the push on demand activation of blue laser imaging technique during gastroscopy.
Experimental: Blue Light Imaging
In this group the participants will be examined by blue laser imaging technique first and secondly with standard white light during the same gastroscopy.
Diagnostic test: blue laser imaging
The intervention is the push on demand activation of blue laser imaging technique during gastroscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection rate of a second cancer or precancerous lesions
Time Frame: The time frame is during the PEG insertion (approximately 15min)
The detection rates for malignant or premalignant lesions in participants with head neck tumors will be compared when using BLI and white light endoscopy
The time frame is during the PEG insertion (approximately 15min)

Collaborators and Investigators

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

Sponsor

Georg Dultz

Investigators

  • Principal Investigator: Mireen Friedrich-Rust, Professor, Goethe University

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)

September 22, 2020

Primary Completion (Actual)

February 2, 2023

Study Completion (Estimated)

August 31, 2024

Study Registration Dates

First Submitted

December 2, 2018

First Submitted That Met QC Criteria

September 22, 2020

First Posted (Actual)

September 28, 2020

Study Record Updates

Last Update Posted (Actual)

July 13, 2023

Last Update Submitted That Met QC Criteria

July 12, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JWGUHMED1-011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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