Fluorescence molecular imaging during bronchoscopy with durvalumab-680LT
DrugFluorescence molecular imaging during bronchoscopy with durvalumab-680LT
NCT Number: NCT07653438
PulmoPrint is a clinical study at the University Medical Center Groningen (UMCG) that investigates why some patients with unresectable stage III lung cancer don't respond to immunotherapy after chemoradiotherapy. To do this, a small dose of a fluorescently labeled version of the immunotherapy drug durvalumab is given via an intravenous (IV) drip, after which a bronchoscopy is performed to visualize where and how much of the drug reaches the tumor and lymph nodes - before the actual durvalumab treatment starts.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 2
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Fluorescence molecular imaging during bronchoscopy with durvalumab-680LT
Time frame: Assessed directly during the bronchoscopy procedure
In vivo fluorescence signal of malignant lesions (pulmonary nodule and/or involved lymph node metastases) assessed semi-quantitatively (tumor-to-background ratio [TBR]/contrast-to-noise ratio) and quantitatively (continuous data by multi-diameter single-fiber reflectance (MDSFR)/single-fiber fluorescence (SFF) spectroscopy [pulmonary lesion] and/or Ultrasound-guided needle biopsy (USNB)/SFF spectroscopy [lymph nodes] measurement). The signal is considered sufficient when a tumor-to-background ratio (TBR) greater than 2 is achieved, assessed both by the fluorescence camera system and by the spectroscopy system. (The comparison of the fluorescence signal between lesion and background is a supportive exploratory analysis intended to characterize signal distribution; it does not constitute evidence of diagnostic or comparative performance.)
Time frame: Up to 2 years
In vivo and ex vivo fluorescence signal, programmed-death ligand 1 (PD-L1) immunohistochemistry (IHC) score (assessed according to standard pathology protocols).
Time frame: Up to 2 years
In vivo and ex vivo fluorescence signal, 1-, 2-and 5-year (long-term exploratory endpoint) event-free survival (EFS).
Time frame: Within 1 week after tracer injection
Adverse events according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: Assessed directly during the bronchoscopy procedure
in vivo tumor-to-background ratio of 15 mg versus 25 mg
Contact information is provided by the study sponsor or research team.
University Medical Center Groningen
Other
In Vivo Fluorescence Molecular Bronchoscopy of Durvalumab-680LT in Patients With Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) After Chemoradiotherapy - PulmoPrint
Acronym: PulmoPrint
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