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

NCT ID: NCT04566367

Last Updated: 2023-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-22

Study Completion Date

2024-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Head Neck Cancer Esophageal Cancer Gastrostomy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This study is a prospective randomised mono centric study with a one to one allocation in two different treatment arms.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants
The participants don't know which arm they were allocated to.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

blue laser imaging

Intervention Type DIAGNOSTIC_TEST

The intervention is the push on demand activation of blue laser imaging technique during gastroscopy.

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.

Group Type EXPERIMENTAL

blue laser imaging

Intervention Type DIAGNOSTIC_TEST

The intervention is the push on demand activation of blue laser imaging technique during gastroscopy.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

blue laser imaging

The intervention is the push on demand activation of blue laser imaging technique during gastroscopy.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Georg Dultz

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Georg Dultz

Record Keeper

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mireen Friedrich-Rust, Professor

Role: PRINCIPAL_INVESTIGATOR

Goethe University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Klinikum der J. W. Goethe-Universität

Frankfurt am Main, Hesse, Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

JWGUHMED1-011

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.