Back to resultsBlue Laser Imaging (BLI) for Detection of Secondary Head and Neck Cancer
Primary Purpose
Head Neck Cancer, Esophageal Cancer, Gastrostomy
Status
Active
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
blue laser imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Head Neck Cancer focused on measuring esophageal cancer, Blue laser imaging, percutaneous endoscopic gastrostomy, head neck cancer
Eligibility 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
Sites / Locations
- Klinikum der J. W. Goethe-Universität
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard White Light Imaging
Blue Light Imaging
Arm Description
In this group the participants will be examined by white light endoscopy first and secondly with blue laser imaging technique during the same gastroscopy.
In this group the participants will be examined by blue laser imaging technique first and secondly with standard white light during the same gastroscopy.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04566367
Brief Title
Blue Laser Imaging (BLI) for Detection of Secondary Head and Neck Cancer
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)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 22, 2020 (Actual)
Primary Completion Date
February 2, 2023 (Actual)
Study Completion Date
August 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Georg Dultz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head Neck Cancer, Esophageal Cancer, Gastrostomy
Keywords
esophageal cancer, Blue laser imaging, percutaneous endoscopic gastrostomy, head neck cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
This study is a prospective randomised mono centric study with a one to one allocation in two different treatment arms.
Masking
Participant
Masking Description
The participants don't know which arm they were allocated to.
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard White Light Imaging
Arm Type
Active Comparator
Arm Description
In this group the participants will be examined by white light endoscopy first and secondly with blue laser imaging technique during the same gastroscopy.
Arm Title
Blue Light Imaging
Arm Type
Experimental
Arm Description
In this group the participants will be examined by blue laser imaging technique first and secondly with standard white light during the same gastroscopy.
Intervention Type
Diagnostic Test
Intervention Name(s)
blue laser imaging
Intervention Description
The intervention is the push on demand activation of blue laser imaging technique during gastroscopy.
Primary Outcome Measure Information:
Title
Detection rate of a second cancer or precancerous lesions
Description
The detection rates for malignant or premalignant lesions in participants with head neck tumors will be compared when using BLI and white light endoscopy
Time Frame
The time frame is during the PEG insertion (approximately 15min)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mireen Friedrich-Rust, Professor
Organizational Affiliation
Goethe University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinikum der J. W. Goethe-Universität
City
Frankfurt am Main
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Blue Laser Imaging (BLI) for Detection of Secondary Head and Neck Cancer
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