Head Neck CancerNCT04566367
Blue Laser Imaging (BLI) for Detection of Secondary Head and Neck Cancer
A study testing blue laser imaging in people with Head Neck Cancer and Esophageal Cancer, run by Georg Dultz at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head Neck Cancer, Esophageal Cancer, Gastrostomy
- What is being tested?
- blue laser imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteGermany
- Study dates
- 22 Sep 2020to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All participants with the need of PEG due to head neck cancers or esophageal carcinoma
Who cannot join
- Minors, pregnant women, contraindication for endoscopy, contraindications for establishment of a PEG
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinikum der J. W. Goethe-Universität
Frankfurt am Main, Hesse, 60590
About this study
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)
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.
Read the 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.
- Conditions
- Head Neck Cancer, Esophageal Cancer, Gastrostomy
- Being tested
- blue laser imaging
- Keywords
- esophageal cancer, Blue laser imaging, percutaneous endoscopic gastrostomy, head neck cancer
- Medical subject headings
- Head and Neck Neoplasms, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blue laser imagingDiagnostic test
The intervention is the push on demand activation of blue laser imaging technique during gastroscopy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: blue laser imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: The time frame is during the PEG insertion (approximately 15min)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start22 Sep 2020
- Primary completion2 Feb 2023
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study is a prospective randomised mono centric study with a one to one allocation in two different treatment arms.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Georg Dultz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Georg Dultz, Johann Wolfgang Goethe University Hospital
- Investigators
- Mireen Friedrich-Rust, Professor, Principal investigator, Goethe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04566367
- Sponsor's protocol ID
- JWGUHMED1-011
- Status last verified
- Jun 2023
- First submitted
- 2 Dec 2018
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04566367
- Acronym / sponsor ID
- JWGUHMED1-011
- Conditions
- Head Neck Cancer, Esophageal Cancer, Gastrostomy
- Keywords
- esophageal cancer, Blue laser imaging, percutaneous endoscopic gastrostomy, head neck cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Georg DultzUniversity, hospital or other
- Study start
- 22 Sep 2020 (actual)
- Primary completion
- 2 Feb 2023 (actual)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 28 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study is a prospective randomised mono centric study with a one to one allocation in two different treatment arms.
| Arm | Type | Receives |
|---|---|---|
| Standard White Light Imaging | Active comparator | Diagnostic Test: blue laser imagingIn this group the participants will be examined by white light endoscopy first and secondly with blue laser imaging technique during the same gastroscopy. |
| Blue Light Imaging | Experimental | Diagnostic Test: blue laser imagingIn this group the participants will be examined by blue laser imaging technique first and secondly with standard white light during the same gastroscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All participants with the need of PEG due to head neck cancers or esophageal carcinoma
Key exclusion criteria (1 listed)
- Minors, pregnant women, contraindication for endoscopy, contraindications for establishment of a PEG
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blue laser imagingThe intervention is the push on demand activation of blue laser imaging technique during gastroscopy. | Diagnostic test | Blue Light Imaging, Standard White Light Imaging |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mireen Friedrich-Rust, Professor principal investigator
Goethe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blue laser imaging in people with Head Neck Cancer and Esophageal Cancer, run by Georg Dultz at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection rate of a second cancer or precancerous lesions (time frame: The time frame is during the PEG insertion (approximately 15min)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2023.