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

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ClinicalTrials.gov Identifier: NCT04566367
Recruitment Status : Recruiting
First Posted : September 28, 2020
Last Update Posted : September 28, 2020
Sponsor:
Information provided by (Responsible Party):
Georg Dultz, Johann Wolfgang Goethe University Hospital

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.

Condition or disease Intervention/treatment Phase
Head Neck Cancer Esophageal Cancer Gastrostomy Diagnostic Test: blue laser imaging Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This study is a prospective randomised mono centric study with a one to one allocation in two different treatment arms.
Masking: Single (Participant)
Masking Description: The participants don't know which arm they were allocated to.
Primary Purpose: Diagnostic
Official Title: Detection Rate by Blue Laser Imaging (BLI) of Secondary or Early Squamous Head and Neck Cancer in Patients Undergoing Elective Percutaneous Endoscopic Gastrostomy (PEG)
Estimated Study Start Date : September 22, 2020
Estimated Primary Completion Date : September 22, 2023
Estimated Study Completion Date : December 1, 2024

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04566367


Contacts
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Contact: Mireen Friedrich-Rust, Professor 06963015333 mireen.friedrich-rust@kgu.de
Contact: Christiana Graf, MD 06963015333 christiana.graf@kgu.de

Locations
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Germany
Klinikum der J. W. Goethe-Universität Recruiting
Frankfurt am Main, Hessen, Germany, 60590
Contact: Mireen Friedrich-Rust, MD       Mireen.Friedrich-Rust@kgu.de   
Sponsors and Collaborators
Georg Dultz
Investigators
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Principal Investigator: Mireen Friedrich-Rust, Professor University Hospital, Frankfurt
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Responsible Party: Georg Dultz, Record Keeper, Johann Wolfgang Goethe University Hospital
ClinicalTrials.gov Identifier: NCT04566367    
Other Study ID Numbers: JWGUHMED1-011
First Posted: September 28, 2020    Key Record Dates
Last Update Posted: September 28, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Georg Dultz, Johann Wolfgang Goethe University Hospital:
esophageal cancer
Blue laser imaging
percutaneous endoscopic gastrostomy
head neck cancer
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Esophageal Neoplasms
Neoplasms by Site
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases