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| ID | Type | Description | Link |
|---|---|---|---|
| 2026-526251-60-00 | EU Trial (CTIS) Number |
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PulmoPrint is a clinical study at UMCG that investigates why some patients with unresectable stage III lung cancer stop responding to immunotherapy after chemoradiation. To do this, a small dose of a fluorescently labeled version of the immunotherapy drug durvalumab is given via an IV drip, after which a camera bronchoscopy is performed to visualize where and how much of the drug actually reaches the tumor and lymph nodes - before the actual durvalumab treatment starts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluorescence molecular imaging during bronchoscopy with durvalumab-680LT at dose of 15 mg | Experimental | Patients will receive an intravenous administration of 15 mg durvalumab-680LT 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. |
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| Fluorescence molecular imaging during bronchoscopy with durvalumab-680LT at dose of 25 mg | Experimental | Patients will receive an intravenous administration of 25 mg durvalumab-680LT 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluorescence molecular imaging during bronchoscopy with durvalumab-680LT | Drug | Fluorescence molecular imaging during bronchoscopy with durvalumab-680LT |
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| Measure | Description | Time Frame |
|---|---|---|
| In vivo fluorescent signal of malignant lesions (pulmonary nodule or involved lymph node metastasis) | In vivo fluorescent signal of malignant lesions (pulmonary nodule or involved lymph node metastasis) assessed semi-quantitatively (tumor-to-background ratio [TBR]/contrast-to-noise ratio) and quantitatively (continuous data by MDSFR/SFF spectroscopy [pulmonary lesion] and/or USNB/SFF spectroscopy [lymph nodes] measurement). The signal is considered sufficient when a 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.) | Assessed directly during the bronchoscopy procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of fluorescence signal with IHC | In vivo and ex vivo fluorescence signal, PD-L1 IHC score (assessed according to standard pathology protocols). | Up to 2 years |
| Correlation of fluorescence signal with EFS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Frederike Bensch, MD, PhD | Contact | 0031503610280 | f.bensch@umcg.nl |
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In vivo and ex vivo fluorescence signal, 1-, 2-and 5-year (long-term exploratory endpoint) event-free survival.
| Up to 2 years |
| Safety of single durvalumab-680LT injection | Adverse events according to CTCAE v5.0 | 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 | Assessed directly during the bronchoscopy procedure |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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