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- Klinische proef NCT07653438
In Vivo Fluorescence Molecular Bronchoscopy of Durvalumab-680LT in Patients With Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) After Chemoradiotherapy (PulmoPrint)
In Vivo Fluorescence Molecular Bronchoscopy of Durvalumab-680LT in Patients With Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) After Chemoradiotherapy - PulmoPrint
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Fase 2
Contacten en locaties
Studiecontact
- Naam: Frederike Bensch, MD, PhD
- Telefoonnummer: 0031503610280
- E-mail: f.bensch@umcg.nl
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- Signed informed consent prior to participation in the study.
- Age ≥ 18 years.
- Histologically or cytologically confirmed unresectable stage III non-small cell lung cancer.
- Completion of concurrent platinum-based chemoradiotherapy
- Eligibility for adjuvant durvalumab per standard of care.
- At least one tumor lesion or involved lymph node accessible by bronchoscopy or endoscopic/endobronchial ultrasound, suitable for biopsy/fine-needle aspiration (FNA) and fluorescence measurement.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Patient is considered fit to undergo a research bronchoscopy (with or without addition of endobronchial ultrasound; including propofol sedation or general anesthesia if either is indicated).
Exclusion Criteria:
- Known history of infusion reactions to durvalumab, other anti-PD-L1 antibodies, or other monoclonal antibodies, according to the patient's medical history.
- Contraindication for bronchoscopy or endoscopic/endobronchial ultrasound (if applicable), including severe uncorrectable coagulopathy, pre-existing severe respiratory insufficiency, or any other clinical reason as judged by the investigator.
- Medical or psychiatric conditions compromising the patient's ability to provide informed consent, according to the treating physician.
- Pregnancy or breastfeeding. A negative pregnancy test must be available for women of childbearing potential on the day of tracer administration.
- Use of an investigational medicinal product within 30 days prior to tracer administration.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Diagnostisch
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Sequentiële toewijzing
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Fluorescence molecular imaging during bronchoscopy with durvalumab-680LT at dose of 15 mg
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 bronchoscopy to visualize the fluorescence signal and MDSFR-SFF spectroscopy to quantify the fluorescence signal in vivo. * MDSFR, multi-diameter single-fiber reflectance spectroscopy; SFF, single-fiber fluorescence spectroscopy |
Fluorescence molecular imaging during bronchoscopy with durvalumab-680LT
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Experimenteel: Fluorescence molecular imaging during bronchoscopy with durvalumab-680LT at dose of 25 mg
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 bronchoscopy to visualize the fluorescence signal and MDSFR-SFF spectroscopy to quantify the fluorescence signal in vivo. * MDSFR, multi-diameter single-fiber reflectance spectroscopy; SFF, single-fiber fluorescence spectroscopy |
Fluorescence molecular imaging during bronchoscopy with durvalumab-680LT
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
In vivo fluorescence signal of malignant lesions (pulmonary nodule and/or involved lymph node metastases)
Tijdsspanne: Assessed directly during the bronchoscopy procedure
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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.)
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Assessed directly during the bronchoscopy procedure
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Comparison of the 15 and 25 mg dose durvalumab-680LT
Tijdsspanne: Assessed directly during the bronchoscopy procedure
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in vivo tumor-to-background ratio of 15 mg versus 25 mg
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Assessed directly during the bronchoscopy procedure
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Correlation of fluorescence signal with immunohistochemistry (IHC)
Tijdsspanne: Up to 2 years
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In vivo and ex vivo fluorescence signal, programmed-death ligand 1 (PD-L1) immunohistochemistry (IHC) score (assessed according to standard pathology protocols).
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Up to 2 years
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Correlation of fluorescence signal with event-free survival (EFS)
Tijdsspanne: Up to 2 years
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In vivo and ex vivo fluorescence signal, 1-, 2-and 5-year (long-term exploratory endpoint) event-free survival (EFS).
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Up to 2 years
|
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Incidence of adverse events after single durvalumab-680LT injection
Tijdsspanne: Within 1 week after tracer injection
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Adverse events according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0
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Within 1 week after tracer injection
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Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
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Laatste update ingediend die voldeed aan QC-criteria
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Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 24296
- 2026-526251-60-00 (Ctis)
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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