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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
20
Fluorescence molecular imaging during bronchoscopy with durvalumab-680LT
In vivo fluorescence signal of malignant lesions (pulmonary nodule and/or involved lymph node metastases)
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: Assessed directly during the bronchoscopy procedure
Correlation of fluorescence signal with immunohistochemistry (IHC)
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
Correlation of fluorescence signal with event-free survival (EFS)
In vivo and ex vivo fluorescence signal, 1-, 2-and 5-year (long-term exploratory endpoint) event-free survival (EFS).
Time frame: Up to 2 years
Incidence of adverse events after single durvalumab-680LT injection
Adverse events according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: Within 1 week after tracer injection
Comparison of the 15 and 25 mg dose durvalumab-680LT
in vivo tumor-to-background ratio of 15 mg versus 25 mg
Time frame: Assessed directly during the bronchoscopy procedure
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