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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

Tracking Information
First Submitted Date  ICMJE December 2, 2018
First Posted Date  ICMJE September 28, 2020
Last Update Posted Date September 28, 2020
Estimated Study Start Date  ICMJE September 22, 2020
Estimated Primary Completion Date September 22, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 22, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Blue Laser Imaging (BLI) for Detection of Secondary Head and Neck Cancer
Official Title  ICMJE Detection Rate by Blue Laser Imaging (BLI) of Secondary or Early Squamous Head and Neck Cancer in Patients Undergoing Elective Percutaneous Endoscopic Gastrostomy (PEG)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Head Neck Cancer
  • Esophageal Cancer
  • Gastrostomy
Intervention  ICMJE Diagnostic Test: blue laser imaging
The intervention is the push on demand activation of blue laser imaging technique during gastroscopy.
Study Arms  ICMJE
  • 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.
    Intervention: Diagnostic Test: blue laser imaging
  • 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.
    Intervention: Diagnostic Test: blue laser imaging
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 22, 2020)
140
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2024
Estimated Primary Completion Date September 22, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mireen Friedrich-Rust, Professor 06963015333 mireen.friedrich-rust@kgu.de
Contact: Christiana Graf, MD 06963015333 christiana.graf@kgu.de
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04566367
Other Study ID Numbers  ICMJE JWGUHMED1-011
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Georg Dultz, Johann Wolfgang Goethe University Hospital
Study Sponsor  ICMJE Georg Dultz
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mireen Friedrich-Rust, Professor University Hospital, Frankfurt
PRS Account Johann Wolfgang Goethe University Hospital
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP