Feasibility of Fluorescence Imaging With Bevacizumab-800CW During Bronchoscopy

Sponsor
University Medical Center Groningen
Study ID
NCT06809946
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Lung Neoplasms
  • Lymph Node Involvement
  • Pulmonary Neoplasms
  • Pulmonary Nodule

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • injection with 15 mg bevacizumab-800CW before bronchoscopy — DRUG
    Patients will receive an intravenous administration of 15 mg bevacizumab-800CW before the bronchoscopy procedure. The bronchoscopy will start with high-definition white light bronchoscopy, followed by fluorescence molecular bronchoscoy to observe the fluorescence signal and MDSFR-SFF spectroscopy to quantify the fluores-cence signal in vivo.
  • injection with 25 mg bevacizumab-800CW before bronchoscopy — DRUG
    Patients will receive an intravenous administration of 15 mg bevacizumab-800CW before the bronchoscopy procedure. The bronchoscopy will start with high-definition white light bronchoscopy, followed by fluorescence molecular bronchoscoy to observe the fluorescence signal and MDSFR-SFF spectroscopy to quantify the fluores-cence signal in vivo.

Study Details

In this feasibility study, bronchoscopy will be combined with fluorescence molecular imaging using the near-infrared fluorescence (NIRF) tracer bevacizumab-800CW for assessment of pulmonary lesions and/or lymph nodes considered to be malignant.

Key Dates

First listed
Feb 5, 2025
Start date
Aug 17, 2026
Status verified
Mar 2026
Primary completion
Aug 17, 2028
Completion
Aug 17, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Fluorescence molecular imaging during bronchoscopy with bevacizumab-800CW at dose of 15 mg
  • Experimental: Fluorescence molecular imaging during bronchoscopy with bevacizumab-800CW at dose of 25 mg

Primary Outcome Measure

Fluorescent signal of malignant lesion versus non-tumorous tissue. [ Time Frame: Assessed directly during the bronchoscopy procedure ]

Central Contacts

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