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

NCT04566367 | Unknown

• 1 other identifier: JWGUHMED1-011
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Head Neck Cancer; Esophageal Cancer; Gastrostomy

Keywords

esophageal cancer; Blue laser imaging; percutaneous endoscopic gastrostomy; head neck cancer

Outcome Measures

Primary Outcomes (1)

• Detection rate of a second cancer or precancerous lesions

  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)

Study Arms (2)

Standard White Light Imaging

ACTIVE COMPARATOR

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

Blue Light Imaging

EXPERIMENTAL

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

Interventions

blue laser imaging DIAGNOSTIC_TEST

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

Blue Light Imaging; Standard White Light Imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Georg Dultz: lead

Study Sites (1)

Klinikum der J. W. Goethe-Universität

Frankfurt am Main, Hesse, 60590, Germany

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Mireen Friedrich-Rust, Professor

  Goethe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants don't know which arm they were allocated to.
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Record Keeper

Model Details: This study is a prospective randomised mono centric study with a one to one allocation in two different treatment arms.

Study Record Dates

• First Submitted: December 2, 2018
• First Posted: September 28, 2020
• Study Start: September 22, 2020
• Primary Completion: February 2, 2023
• Study Completion: August 31, 2024
• Last Updated: July 13, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)