In Vivo Fluorescence Molecular Bronchoscopy of Durvalumab-680LT in Patients With Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) After Chemoradiotherapy - PulmoPrint
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- In vivo fluorescence signal of malignant lesions (pulmonary nodule and/or involved lymph node metastases)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •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).
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Fluorescence molecular imaging during bronchoscopy with durvalumab-680LT (Drug)
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
干预措施: Fluorescence molecular imaging during bronchoscopy with durvalumab-680LT (Drug)
结局指标
主要结局
In vivo fluorescence signal of malignant lesions (pulmonary nodule and/or involved lymph node metastases)
时间窗: 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.)
次要结局
- Correlation of fluorescence signal with immunohistochemistry (IHC)(Up to 2 years)
- Correlation of fluorescence signal with event-free survival (EFS)(Up to 2 years)
- Incidence of adverse events after single durvalumab-680LT injection(Within 1 week after tracer injection)