JOURNAL ONKOLOGIE – STUDIE
Blue Laser Imaging (BLI) for Detection of Secondary Head and Neck Cancer
Rekrutierend
NCT-Nummer:
NCT04566367
Studienbeginn:
September 2020
Letztes Update:
28.09.2020
Wirkstoff:
-
Indikation (Clinical Trials):
Head and Neck Neoplasms, Esophageal Neoplasms
Geschlecht:
Alle
Altersgruppe:
Erwachsene (18+)
Phase:
-
Sponsor:
Georg Dultz
Collaborator:
-
Studienleiter
Principal Investigator
University Hospital, Frankfurt
Kontakt
Kontakt:
Phone: 06963015333
E-Mail: mireen.friedrich-rust@kgu.de» Kontaktdaten anzeigen
Kontakt:
Phone: 06963015333
E-Mail: christiana.graf@kgu.de» Kontaktdaten anzeigen
Studienlocations
(1 von 1)
60590 Frankfurt am Main
(Hessen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Mireen Friedrich-Rust, MD
E-Mail: Mireen.Friedrich-Rust@kgu.de» Ansprechpartner anzeigen
Studien-Informationen
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.
Ein-/Ausschlusskriterien
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
Studien-Rationale
Primary outcome: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
Studien-Arme
- 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. - 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.
Geprüfte Regime
- blue laser imaging:
The intervention is the push on demand activation of blue laser imaging technique during gastroscopy.
Quelle: ClinicalTrials.gov
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