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REFLECT; Real-time targeted fluorescence endoscopy for detection of the primary cancer lesion in patients with a metastasis of unknown primary tumor in the head and neck

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-513897-23-00
Acronym
10949
Enrollment
35
Registered
2024-11-08
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unknown primary tumour of the head and neck

Brief summary

Macroscopic fluorescent signal levels and tracer distribution observed with TFE, Detection rates of TFE and WLE

Detailed description

Patient characteristics (age, sex, BMI, history and morbidity, localization of primary tumor and lymph node metastasis, vital parameters and presence of symptoms before and after tracer administration), Macroscopic fluorescent signal levels and tracer distribution observed with flexible fluorescence laryngoscopy, Quantification of intrinsic fluorescence signals observed using the MDSFR/SFF probe, Macroscopic fluorescent signal levels and tracer distribution observed with ex vivo imaging of FSA and mucosectomy specimens, Histopathologic characteristics of biopsied specimens including HPV-status, Results of the quality of life questionnaires QLQ-C30, QLQH&N35 and SWAL-QOL

Interventions

DRUGErbitux 5 mg/mL solution for infusion

Sponsors

Universitair Medisch Centrum Groningen
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Macroscopic fluorescent signal levels and tracer distribution observed with TFE, Detection rates of TFE and WLE

Secondary

MeasureTime frame
Patient characteristics (age, sex, BMI, history and morbidity, localization of primary tumor and lymph node metastasis, vital parameters and presence of symptoms before and after tracer administration), Macroscopic fluorescent signal levels and tracer distribution observed with flexible fluorescence laryngoscopy, Quantification of intrinsic fluorescence signals observed using the MDSFR/SFF probe, Macroscopic fluorescent signal levels and tracer distribution observed with ex vivo imaging of FSA and mucosectomy specimens, Histopathologic characteristics of biopsied specimens including HPV-status, Results of the quality of life questionnaires QLQ-C30, QLQH&N35 and SWAL-QOL

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026